Premarket Approval Decisions for March 2002

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for March 2002. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.

PMA Original Approvals

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
P990065 3/5/02	SIR-Spheres®	Sirtex Medical, Inc. North Ryde, Australia 2113	Approval for SIR-Spheres®. The device is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).
P010025 3/15/02	Lorad Digital Breast Imager (LDBI)	Hologic, Inc. Bedford, MA 01730	Approval for the Lorad Digital Breast Imager. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film mammographic systems.
P010040 3/15/02	Disintegrator™ Insulin Needle Destruction Device	Safeguard Medical Devices, Inc. Broadview Heights, OH 44147	Approval for the Disintegrator™ Insulin Needle Destruction Device. The device is indicated for insulin needle destruction for home use.
P010043 3/14/02	Lea’s Shield® Barrier Contraceptive	Yama, Inc. Millburn, NJ 07041	Approval for the Lea’s Shield® Barrier Contraceptive. The device is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.
P010049 3/25/02	QuickSeal Femoral Arterial Closure System	SUB-Q, Inc. San Clemente, CA 92673	Approval for the QuickSeal Femoral Arterial Closure System. The device is indicated for the delivery of Gelfoam® for the extravascular closure of the femoral artery access site. The system is indicated for use in reducing time to hemostasis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 French or smaller procedural sheaths. The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures.

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

P990065

3/5/02

SIR-Spheres®

Sirtex Medical, Inc.

North Ryde, Australia

2113

Approval for SIR-Spheres®. The device is indicated for the treatment of unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (IHAC) of FUDR (Floxuridine).

P010025

3/15/02

Lorad Digital Breast Imager (LDBI)

Hologic, Inc.

Bedford, MA

01730

Approval for the Lorad Digital Breast Imager. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film mammographic systems.

P010040

3/15/02

Disintegrator™ Insulin Needle Destruction Device

Safeguard Medical Devices, Inc.

Broadview Heights, OH

44147

Approval for the Disintegrator™ Insulin Needle Destruction Device. The device is indicated for insulin needle destruction for home use.

P010043

3/14/02

Lea’s Shield® Barrier Contraceptive

Yama, Inc.

Millburn, NJ

07041

Approval for the Lea’s Shield® Barrier Contraceptive. The device is indicated for use by women of childbearing age who desire to prevent or postpone pregnancy.

P010049

3/25/02

QuickSeal Femoral Arterial Closure System

SUB-Q, Inc.

San Clemente, CA

92673

Approval for the QuickSeal Femoral Arterial Closure System. The device is indicated for the delivery of Gelfoam® for the extravascular closure of the femoral artery access site. The system is indicated for use in reducing time to hemostasis at femoral artery puncture sites and in reducing time to ambulation in patients who have undergone diagnostic or interventional procedures using 8 French or smaller procedural sheaths. The device reduces time to eligibility for hospital discharge in patients who have undergone diagnostic or interventional procedures and reduces time to actual hospital discharge in patients who have undergone diagnostic procedures.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
N18033/S037 3/18/02 Special	ACUVUE® 2 COLOURS™ Brand (etafilcon A) Contact Lens with UV Blocker	Vistakon®, Division of Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Approval for labeling changes for the device. The changes will add additional statements to the "Precautions" section of the Package Insert to alert both doctors and patients about visual symptoms and/or peripheral awareness that patients might experience due to a reduction in the visible light transmission. The following additional precaution statement will be added to the Package Insert: "Due to reduction in light transmittance with cosmetically tinted lenses, some patients may experience visual symptoms while wearing ACUVUE® 2 COLOURS Brand. In addition, some patients may experience peripheral awareness due to the opaque iris pattern." The following additional precaution statement will be added to the Patient Instruction Guides: "When wearing lenses that alter your eye color, you may notice temporary differences in your vision due to a change in the amount of light that enters your eyes. If these differences in vision persist when wearing ACUVUE® 2 COLOURS Brand, it is important that you consult your Eye Care Professional."
P800012/S008 3/5/02 180-Day	Drilac Granules	Kensey Nash Corporation Exton, PA 19341	Approval for a manufacturing facility located at Kensey Nash Corporation, Exton, Pennsylvania. The granulation and syringe cutting processes will be conducted at this facility.
P810002/S057 3/4/02 180-Day	St. Jude Medical® Regent™ Mechanical Heart Valve (aortic)	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for a modified version of the SJM Standard Valve, sizes 19, 21, 23, 25 and 27 mm. The device, as modified, will be marketed under the trade name Regent™ Mechanical Heart Valve and is indicated as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted prosthetic heart valve.
P840064/S023 3/25/02 Special	VISCOAT® Ophthalmic Viscosurgical Device	Alcon Research, Ltd. Fort Worth, TX 76134	Approval for adding syringe assembly illustrations and instructions to the PROVISC® portion of the DUOVISC® insert to enhance the safe use of the device. The PROVISC syringe assembly instructions will standardize instructions within the DUOVISC insert.
P850051/S057 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P890003/S065 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P890003/S068 4/12/02 180-Day	Model 9990 Desktop Software and Model 9767/9767L Telemetry Programming Head (Telemetry B)	Medtronic, Inc. Minneapolis, MN 55432	Approval for Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B). The device, as modified, will be marketed under the trade name Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
P890023/S013 3/11/02 180-Day	BIOMEDICS® UV Asphere (ocufilcon D) Contact Lenses for Extended Wear (up to 7 days/ 6 nights of extended wear)	Ocular Sciences, Inc. Hampsire, UK S053 4ND	Approval for BIOMEDICS® UV Asphere (ocufilcon D) Contact Lenses indicated for extended wear (up to 7 days/ 6 nights). The sponsor also requested approval of the subject devices to include a statement that the UV absorbing contact lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye. The device, as modified, will be marketed under the trade name referenced above with the following indication: The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than –2.00 diopters that does not interfere with visual acuity. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lenses may be prescribed for daily wear or extended wear. For extended wear, the lens may be prescribed for up to 7 days/6 nights between removals for cleaning and disinfection; or for disposable wear as directed by the eye care practitioner. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lenses may be prescribed for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using a chemical (not heat) or hydrogen peroxide disinfecting system. The BIOMEDICS® UV Asphere (ocufilcon D) Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
P890047/S014 3/25/02 Special	PROVISC® Ophthalmic Viscosurgical Device	Alcon Research, Ltd. Fort Worth, TX 76134	Approval for adding syringe assembly illustrations and instructions to enhance the safe use of the device.
P890055/S014 3/29/02 Real-Time	Model 3000 Series Implantable Infusion Pumps	Arrow International Inc. Walpole, MA 02081	Approval for an alternate Quick Start Technique to the pump implant procedure.
P900009/S015 3/29/02 180-Day	Exogen 3000 Sonic Accelerated Fracture Healing System	Smith & Nephew, Inc. Memphis, TN 38116	Approval for the manufacturing facility located at Smith & Nephew, Inc., Memphis, Tennessee.
P900043/S033 3/5/02 Special	BX Velocity Stent on Raptorrail Stent Delivery (RX) and BX Velocity with hepacoat on Raptorrail Stent Delivery System	Cordis Corporation Warren, NJ 07059	Approval for two changes to the Quality Plan for the products.
P900043/S034 3/5/02 Special	BX Velocity Balloon-Expandable Stent System with Raptor Over-the-Wire Delivery System and BX Velocity with hepacoat on Raptor Stent System	Cordis Corporation Warren, NJ 07059	Approval for a change to the Quality Plan for the products.
P900061/S049 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P910023/S060 3/1/02 Special	Photon Micro Model V-194 and V-232 and Atlas Model V-199 and V-240 Implantable Cardioverter Defibrillators	St. Jude Medical, Inc. Sunnyvale, CA 94086	Approval for an additional screening procedure to confirm output flex performance.
P920004/S016 3/7/02 Special	VasoSeal® VHD & ES Devices	Datascope Corporation MahWah, NJ 07430	Approval for a change in the instructions for use. Specifically, to remove the occlusive pressure while maintaining adhesive (device) plunger pressure and positions after the first collagen cartridge has been deployed.
P930022/S001 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P930038/S033 3/20/02 Special	Angio-Seal™ Vascular Closure Device	St. Jude Medical, Inc. Minnetonka, MN 55345	Approval for 3 changes to the instructions for use for the Angio-Seal™ device family.
P950021/S004 3/19/02 180-Day	Oncogene Science Total PSA Microtiter ELISA	Oncogene Science/Bayer Corporation Cambridge, MA 02142	Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name Oncogene Science Total PSA Microtiter ELISA and is indicated for the following: The Oncogene Science Total PSA Microtiter ELISA is an in vitro diagnostic assay intended to quantitatively measure total PSA in human serum. The assay detects PSA both as a free molecule, and when complexed by other molecules, principally α-1-antichymotrypsin (ACT). This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The Oncogene Science Total PSA Microtiter ELISA is further indicated for follow-up and monitoring of patients with prostate cancer. PSA levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.
P950021/S005 3/13/02 180-Day	Total PSA Microtiter ELISA	Oncogene Science Cambridge, MA 02142	Approval for manufacturing sites located at Bayer Diagnostics, Elkhart, Indiana and Oncogene Science, Cambridge, Massachusetts.
P950022/S014 3/11/02 Real-Time	Riata™ Series 1500 Defibrillation Lead System	St. Jude Medical, Inc. Sunnyvale, CA 94086	Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name Riata™ Series 1500 (Models 1570, 1571, 1580 and 1581) Defibrillation Lead System and accessories (S-65-S, S-65-F, S-65-X, TX-070). These devices are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications.). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.
P950032/S029 3/14/02 Real-Time	Apligraf	Organogenesis, Inc. Canton, MA 02021	Approval of a new cell strain for the production of Apligraf (i.e., HEP990), and the replacement of flow cytometric allogenicity and immuno-phenotyping assays used in cell strain characterization with a similar cell purity assay.
P960013/S010 3/27/02 Real-Time	The Locator™ Steerable Stylet Model 4036 for use with Tendril DX Model 1388 T/TC/K and Tendril SDX Model 1488 T/TC/K Endocardial Pacing Leads	St. Jude Medical, Inc. Sylmar, CA 91392	Approval for The Locator™ Steerable Stylet Model 4036 for use with Tendril DX Model 1388 T/TC/K and Tendril SDX Model 1488 T/TC/K Endocardial Pacing Leads.
P960025/S008 3/1/02 180-Day	Lumbar I/F Cage® System	DePuy AcroMed Raynham, MA 02767	Approval for a wedged version of the I/F Cage component. The indication for these implants has not been changed from that approved on February 2, 1999.
D970003/S016 3/20/02 180-Day	INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemaker System: Pacemaker software version 1.08, Programmer/ Recorder/Monitor Model 2892 Software, Version 1.10/1.11, Entra SSI, GDT Model 484, ITM Model 1326, Entra SSI, GDT Model 485, ITM Model 1325, Entra SSIR, GDT Model 1198, ITM Model 1398, Entra SSIR, GDT Model 1195, ITM Model 1395, Entra DDD, GDT Model 986, ITM Model 1426, Entra DDD, GDT Model 985, ITM Model 1425, Entra DDDR, GDT Model 1294, ITM Model 1494, Entra DDDR, GDT Model 1295, ITM Model 1495, Entra DDDR, GDT Model 1296, ITM Model 1466, Plus SSIR, GDT Model 1194, ITM Model 1394, Plus DDDR, GDT Model 1298, ITM Model 1468, Plus DDDR, GDT Model 1297, ITM Model 1467	Guidant Corporation St. Paul, MN 55112	Approval for the INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemaker System. The INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemakers are indicated for treatment of the following: 1) Symptomatic paroxysmal or permanent second- or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block); 4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes. Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in MV and/or level of physical activity (INSIGNIA I Plus only). The INSIGNIA I Entra and Plus pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-Chamber modes are specifically indicated for treatment of the following: 1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.
P970003/S038 3/28/02 Real-Time	NeuroCybernetic Prosthesis (NCP®) System, Model, 250 Programming Software, Versions 4.6 and 6.1	Cyberonics, Inc. Houston, TX 77058	Approval for modifications to the existing Model 250 Programming Software, resulting in new Versions 4.6 and 6.1.
P970012/S013 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P970035/S031 3/1/02 180-Day	Medtronic AVE S7 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent System	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval to update the Medtronic AVE S7 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent System labeling to include 6-month post-procedure results for the study population.
P970051/S019 3/21/02 180-Day	Nucleus 24 Cochlear Implant System for Adults and Children with ESPrit3G Behind-the-Ear Speech Processor	Cochlear Americas Englewood, CO 80112	Approval for the SP-10 Behind-the-Ear Speech Processor with ACE, CIS and SPEAK speech coding strategies. The device, as modified, will be marketed under the trade name ESPrit3G and is intended to be used with the CI24M, CI24R(ST) and CI24R(CS) cochlear implants.
P980016/S023 3/1/02 180-Day	Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™ DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B)	Medtronic, Inc. Minneapolis, MN 55432	Approval for Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™ DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B). The device, as modified, will be marketed under the trade name Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
P980016/S027 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P980023/S006 3/11/02 Real-Time	Belos VR Implantable Cardioverter Defibrillator (ICD) System and Programmer Software Cartridge I-K01.0.A/4	Biotronik, Inc. Lake Oswego, OR 97035	Approval for programmer software cartridge I-K01.0.A/4, minor embedded software changes, minor hardware changes, and a correction to the "Use Before" date.
P980035/S021 3/18/02 180-Day	Medtronic Kappa 700 Series Pulse Generator (selected models)	Medtronic, Inc. Minneapolis, MN 55432	Approval for an alternate manufacturing facility located at Medtronic Arizona Device Manufacturing, Tempe, Arizona.
P980035/S022 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P980035/S023 3/15/02 Special	Medtronic Kappa 700/600 Models: KVDD701, KDR721, KDR731, KDR733 and Medtronic Kappa 900/800 Models: KVDD901, KDR921, KDR931, KDR933	Medtronic, Inc. Minneapolis, MN 55432	Approval for two changes in the manufacturing process involving the epoxy dispense program and the wire bond loop program.
P980050/S012 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P980052/S001 3/1/02 180-Day	TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System	TMJ Concepts Camarillo, CA 93012	Approval for a manufacturing site located at TMJ Concepts, Ventura, California.
P990001/S009 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P990016/S002 3/28/02 180-Day	McCue CUBA Clinical Ultrasonic Bone Sonometry System	McCue Corporation, Inc. Winchester, UK SO21-2AS	Approval of the CUBAClinical Data Controller (Data Controller). The Data Controller is a hand-held control device that enables the user to operate the CUBAClinical without the computer and the software for data analysis. The modifications to the Bone Sonometer consist of the integration of the Data Controller and associated software, simple replacement of the CUBAClinical serial connector, and Data Controller operating instructions. The results are displayed on an LCD screen display and the printout shows a graphical display of patient data.
P990026/S011 3/21/02 180-Day	GlucoWatch®2 Biographer	Cygnus, Inc. Redwood City, CA 94063	Approval for modifications to the electrical hardware and software of the original GlucoWatch Automatic Glucose Biographer. The device, as modified, will be marketed under the trade name GlucoWatch®2 Biographer and is indicated for: The GlucoWatch®2 Biographer is a glucose monitoring device intended for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. This device is intended for use by patients at home and in healthcare facilities. The device is for prescription use only. The GlucoWatch®2 Biographer is intended for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. The GlucoWatch®2 Biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of Biographer results should be based on the trends and patterns seen with several sequential readings over time.
P990027/S005 3/13/02 180-Day	Technolas 217A Excimer Laser System	Bausch & Lomb, Inc. San Dimas, CA 91773	Approval for a manufacturing facility located at Bausch & Lomb Technolas GmbH, Feldkirchen, Germany.
P990030/S003 3/14/02 180-Day	CoStasis®/ DynaStat™ Surgical Hemostats	Cohesion Technologies Palo Alto, CA 94303	Approval of the urological exclusion from the "Indications for Use" statement. The device, as modified, will be marketed under the trade names CoStasis®/DynaStat™ Surgical Hemostat and is indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to the hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
P990034/S002 3/11/02 Real-Time	Medtronic® IsoMed® Model 8472 Fixed Rate Infusion System	Medtronic, Inc. Minneapolis, MN 55432	Approval for: 1) propellant change from CFC-114 to n-Butane; 2) capillary tubing adjustment as a result of change to n-Butane; and 3) updates to the Technical Manual.
P990038/S002 3/7/02 180-Day	DiaSorin ETI-MAK-2 PLUS Assay	DiaSorin, Inc. Stillwater, MN 55082	Approval for inclusion of the instrument reproducibility study in the package insert.
P990041/S001 3/7/02 180-Day	DiaSorin ETI-AB-EBK PLUS Assay	DiaSorin, Inc. Stillwater, MN 55082	Approval for reproducibility studies using serum in the package insert.
P990042/S002 3/5/02 180-Day	DiaSorin ETI-AB-AUK PLUS Assay	DiaSorin, Inc. Stillwater, MN 55082	Approval for inclusion of plasma reproducibility studies in the package insert.
P990043/S002 3/11/02 180-Day	DiaSorin ETI-EBK PLUS Assay	DiaSorin, Inc. Saluggia, Italy	Approval for inclusion of the instrument reproducibility study in the package insert.
P990044/S001 3/6/02 180-Day	DiaSorin ETI-CORE-IGMK PLUS Assay	DiaSorin, Inc. Stillwater, MN 55082	Approval for inclusion of reproducibility studies in the package insert.
P990045/S002 3/7/02 180-Day	DiaSorin ETI-AB-COREK PLUS Assay	DiaSorin, Inc. Stillwater, MN 55082	Approval for inclusion of the instrument reproducibility study in the package insert.
P990055/S002 3/19/02 180-Day	Oncogene Science Complexed PSA Microtiter ELISA	Oncogene Science Cambridge, MA 02142	Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name Oncogene Science Complexed PSA Microtiter ELISA and is indicated for the following: The Oncogene Science Complexed PSA Microtiter ELISA is an in vitro diagnostic assay intended to quantitatively measure Complexed PSA (cPSA) in human serum. This device is indicated for the measurement of serum cPSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The Oncogene Science Complexed PSA Microtiter ELISA is further indicated for follow-up and monitoring of patients with prostate cancer. cPSA levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.
P990055/S003 3/13/02 180-Day	Complexed PSA Microtiter ELISA	Oncogene Science Cambridge, MA 02142	Approval for manufacturing sites located at Bayer Diagnostics, Elkhart, Indiana and Oncogene Science, Cambridge, Massachusetts.
P000007/S002 3/26/02 180-Day	Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P	Edwards Lifesciences LLC Irvine, CA 92614	Approval for the size 29 mm Prima Plus Stentless Bioprosthesis.
P000009/S003 3/11/02 Real-Time	Tachos DR Implantable Cardioverter Defibrillator (ICD) System and Programmer Software Cartridge I-KDR.0.U	Biotronik, Inc. Lake Oswego, OR 97053	Approval for programmer software cartridge I-KDR.0.U, embedded software changes and minor hardware changes to the Tachos DR ICD.
P000011/S004 3/1/02 180-Day	Phosphorylcholine (PC) coated BiodivYsio™ OC stent premounted on the Over-the-Wire (OTW) delivery system (BiodivYsio™ OC OTW)	Biocompatibles Cardiovascular, Inc. Andover, MA 01810	Approval for the BiodivYsio™ OC OTW in 11 mm, 15 mm, 18 mm, 22 mm and 28 mm stent lengths and 3.0 mm, 3.5 mm and 4.0 mm diameters. The device, as modified, will be marketed under the trade name BiodivYsio™ OC OTW and is indicated for: "use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length ≤ 25 mm) with a reference vessel diameter ranging from ≥ 3.0 mm to ≤4.0 mm and intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this implant is unknown at present."
P000018/S018 3/25/02 180-Day	Novoste™ 60 mm Beta-Cath™ 5 Fr System	Novoste Corporation Norcross, GA 30093	Approval for the Novoste™ Beta-Cath™ 60 mm 5 Fr System. The Novoste™ Beta-Cath™ 60 mm 5 Fr System is intended to deliver beta radiation to the site of successful percutaneous coronary intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions with injury areas up to 40 mm in a reference vessle diameter ranging from 2.7 mm to 4.0 mm.
P000036/S002 3/19/02 Special	DERMAGRAFT	Advanced Tissue Sciences, Inc. La Jolla, CA 92037	Approval for a change in the Caution statement in the Directions for Use from "Do not use Dermagraft after the expiration date" to "Do not use Dermagraft after the expiration date indicated on the labeled unit carton."
P000037/S001 3/6/02 Panel	On-X® Prosthetic Heart Valve, Models ONXM and ONXMC	Medical Carbon Research Institute, LLC Austin, TX 78754	Approval for the On-X® Prosthetic Heart Valve, Model ONXM in sizes 25 mm, 27/29 mm, 31/33 mm, and Model ONXMC in size 25/33 mm in the mitral position. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the mitral position.
P000039/S001 3/27/02 180-Day	AMPLATZER® Septal Occluder (ASO) Device	AGA Medical Corporation Golden Valley, MN 55427	Approval for the post-approval study protocol for the AMPLATZER® Septal Occluder (ASO) Device.
P010015/S006 3/13/02 180-Day	Medtronic/Vitatron CareLink Programmer Model 2090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.
P010030/S002 3/20/02 Real-Time	LifeVest™ (formerly (WCD®) 2000 System)	Lifecor, Inc. Pittsburgh, PA 15238	Approval for a new trade name for the WCD® device. The device, as modified, will be marketed under the trade name LifeVest™ and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

N18033/S037

3/18/02

Special

ACUVUE® 2 COLOURS™ Brand (etafilcon A) Contact Lens with UV Blocker

Vistakon®, Division of Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Approval for labeling changes for the device. The changes will add additional statements to the "Precautions" section of the Package Insert to alert both doctors and patients about visual symptoms and/or peripheral awareness that patients might experience due to a reduction in the visible light transmission. The following additional precaution statement will be added to the Package Insert: "Due to reduction in light transmittance with cosmetically tinted lenses, some patients may experience visual symptoms while wearing ACUVUE® 2 COLOURS Brand. In addition, some patients may experience peripheral awareness due to the opaque iris pattern." The following additional precaution statement will be added to the Patient Instruction Guides: "When wearing lenses that alter your eye color, you may notice temporary differences in your vision due to a change in the amount of light that enters your eyes. If these differences in vision persist when wearing ACUVUE® 2 COLOURS Brand, it is important that you consult your Eye Care Professional."

P800012/S008

3/5/02

180-Day

Drilac Granules

Kensey Nash Corporation

Exton, PA

19341

Approval for a manufacturing facility located at Kensey Nash Corporation, Exton, Pennsylvania. The granulation and syringe cutting processes will be conducted at this facility.

P810002/S057

3/4/02

180-Day

St. Jude Medical® Regent™ Mechanical Heart Valve (aortic)

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for a modified version of the SJM Standard Valve, sizes 19, 21, 23, 25 and 27 mm. The device, as modified, will be marketed under the trade name Regent™ Mechanical Heart Valve and is indicated as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic valve. This device may also be used to replace a previously implanted prosthetic heart valve.

P840064/S023

3/25/02

Special

VISCOAT® Ophthalmic Viscosurgical Device

Alcon Research, Ltd.

Fort Worth, TX

76134

Approval for adding syringe assembly illustrations and instructions to the PROVISC® portion of the DUOVISC® insert to enhance the safe use of the device. The PROVISC syringe assembly instructions will standardize instructions within the DUOVISC insert.

P850051/S057

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic/Vitatron Carelink Programmer Model 2090, Model 2067 CareLink Programmer RF Head, Model 2290 Lead Analyzer, Model 2292 Analyzer Cable, Model 2091 CareLink Programmer Modem, Model 8190 Software for the Model 2290 Lead Analyzer, Model 5437A Programmer Interface Cable, Model 2090 EC ECG Cable, Model 2090 AB Cable, Model 2090 TPS Touchpen, Model 2090 RV Remote View Software, Model 9964 CareLink Programmer Software for the GEM II DR ICD (Model 7273), Model 9966 CareLink Programmer Software for the Marquis DR ICD, Model 9896 CareLink Programmer Software for the Jewel (Model 7218), and Vitatron Model VSC02 version 6.1 CareLink Programmer Software. In addition, this submission includes the following programmer software applications (previously approved for other Medtronic, Vitatron, or CPI programmers) that have been modified for use with the Model 2090 CareLink Programmer: Vitatron ProVit Model VSA02 v6.1, Kappa 400 (9952/A), Kappa 600/700 (9953/A), Kappa 800/900 (9988), Sigma (9963/A), InSync (9980), Reveal Plus (9809), Analyzer (8190), GEM (9962), GEM DR (9960), GEM II VR (9965), GEM II DR (9964), GEM III VR (9971), GEM III DR (9970), GEM III AT (9974), Baseline 7 (9891/A), CPI Prelude (9892), CPI Triumph (9892), Jewel PCD (9895), Jewel CD (9895), Jewel AF (9961), Jewel Plus (9895), PCD (9895), Preva D, ST-DR (9959, Jewel (9894), Jewel II (9955). The device, as modified, will be marketed under the trade name Medtronic/ Vitatron CareLink Programmer Model 2090 and is indicated for use in the interrogation and programming of implantable medical devices.

P890003/S065

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P890003/S068

4/12/02

180-Day

Model 9990 Desktop Software and Model 9767/9767L Telemetry Programming Head (Telemetry B)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B). The device, as modified, will be marketed under the trade name Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P890023/S013

3/11/02

180-Day

BIOMEDICS® UV Asphere (ocufilcon D) Contact Lenses for Extended Wear (up to 7 days/ 6 nights of extended wear)

Ocular Sciences, Inc.

Hampsire, UK

S053 4ND

Approval for BIOMEDICS® UV Asphere (ocufilcon D) Contact Lenses indicated for extended wear (up to 7 days/ 6 nights). The sponsor also requested approval of the subject devices to include a statement that the UV absorbing contact lenses help to protect against transmission of harmful UV radiation to the cornea and into the eye. The device, as modified, will be marketed under the trade name referenced above with the following indication: The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than –2.00 diopters that does not interfere with visual acuity. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lenses may be prescribed for daily wear or extended wear. For extended wear, the lens may be prescribed for up to 7 days/6 nights between removals for cleaning and disinfection; or for disposable wear as directed by the eye care practitioner. The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lenses may be prescribed for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using a chemical (not heat) or hydrogen peroxide disinfecting system. The BIOMEDICS® UV Asphere (ocufilcon D) Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

P890047/S014

3/25/02

Special

PROVISC® Ophthalmic Viscosurgical Device

Alcon Research, Ltd.

Fort Worth, TX

76134

Approval for adding syringe assembly illustrations and instructions to enhance the safe use of the device.

P890055/S014

3/29/02

Real-Time

Model 3000 Series Implantable Infusion Pumps

Arrow International Inc.

Walpole, MA

02081

Approval for an alternate Quick Start Technique to the pump implant procedure.

P900009/S015

3/29/02

180-Day

Exogen 3000 Sonic Accelerated Fracture Healing System

Smith & Nephew, Inc.

Memphis, TN

38116

Approval for the manufacturing facility located at Smith & Nephew, Inc., Memphis, Tennessee.

P900043/S033

3/5/02

Special

BX Velocity Stent on Raptorrail Stent Delivery (RX) and BX Velocity with hepacoat on Raptorrail Stent Delivery System

Cordis Corporation

Warren, NJ

07059

Approval for two changes to the Quality Plan for the products.

P900043/S034

3/5/02

Special

BX Velocity Balloon-Expandable Stent System with Raptor Over-the-Wire Delivery System and BX Velocity with hepacoat on Raptor Stent System

Cordis Corporation

Warren, NJ

07059

Approval for a change to the Quality Plan for the products.

P900061/S049

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P910023/S060

3/1/02

Special

Photon Micro Model V-194 and V-232 and Atlas Model V-199 and V-240 Implantable Cardioverter Defibrillators

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for an additional screening procedure to confirm output flex performance.

P920004/S016

3/7/02

Special

VasoSeal® VHD & ES Devices

Datascope Corporation

MahWah, NJ

07430

Approval for a change in the instructions for use. Specifically, to remove the occlusive pressure while maintaining adhesive (device) plunger pressure and positions after the first collagen cartridge has been deployed.

P930022/S001

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P930038/S033

3/20/02

Special

Angio-Seal™ Vascular Closure Device

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for 3 changes to the instructions for use for the Angio-Seal™ device family.

P950021/S004

3/19/02

180-Day

Oncogene Science Total PSA Microtiter ELISA

Oncogene Science/Bayer Corporation

Cambridge, MA

02142

Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name Oncogene Science Total PSA Microtiter ELISA and is indicated for the following: The Oncogene Science Total PSA Microtiter ELISA is an in vitro diagnostic assay intended to quantitatively measure total PSA in human serum. The assay detects PSA both as a free molecule, and when complexed by other molecules, principally α-1-antichymotrypsin (ACT). This device is indicated for the measurement of serum PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The Oncogene Science Total PSA Microtiter ELISA is further indicated for follow-up and monitoring of patients with prostate cancer. PSA levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.

P950021/S005

3/13/02

180-Day

Total PSA Microtiter ELISA

Oncogene Science

Cambridge, MA

02142

Approval for manufacturing sites located at Bayer Diagnostics, Elkhart, Indiana and Oncogene Science, Cambridge, Massachusetts.

P950022/S014

3/11/02

Real-Time

Riata™ Series 1500 Defibrillation Lead System

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for new defibrillation lead systems and accessories. The devices, as modified, will be marketed under the trade name Riata™ Series 1500 (Models 1570, 1571, 1580 and 1581) Defibrillation Lead System and accessories (S-65-S, S-65-F, S-65-X, TX-070). These devices are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications.). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart.

P950032/S029

3/14/02

Real-Time

Apligraf

Organogenesis, Inc.

Canton, MA

02021

Approval of a new cell strain for the production of Apligraf (i.e., HEP990), and the replacement of flow cytometric allogenicity and immuno-phenotyping assays used in cell strain characterization with a similar cell purity assay.

P960013/S010

3/27/02

Real-Time

The Locator™ Steerable Stylet Model 4036 for use with Tendril DX Model 1388 T/TC/K and Tendril SDX Model 1488 T/TC/K Endocardial Pacing Leads

St. Jude Medical, Inc.

Sylmar, CA

91392

Approval for The Locator™ Steerable Stylet Model 4036 for use with Tendril DX Model 1388 T/TC/K and Tendril SDX Model 1488 T/TC/K Endocardial Pacing Leads.

P960025/S008

3/1/02

180-Day

Lumbar I/F Cage® System

DePuy AcroMed

Raynham, MA

02767

Approval for a wedged version of the I/F Cage component. The indication for these implants has not been changed from that approved on February 2, 1999.

D970003/S016

3/20/02

180-Day

INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemaker System: Pacemaker software version 1.08, Programmer/ Recorder/Monitor Model 2892 Software, Version 1.10/1.11, Entra SSI, GDT Model 484, ITM Model 1326, Entra SSI, GDT Model 485, ITM Model 1325, Entra SSIR, GDT Model 1198, ITM Model 1398, Entra SSIR, GDT Model 1195, ITM Model 1395, Entra DDD, GDT Model 986, ITM Model 1426, Entra DDD, GDT Model 985, ITM Model 1425, Entra DDDR, GDT Model 1294, ITM Model 1494, Entra DDDR, GDT Model 1295, ITM Model 1495, Entra DDDR, GDT Model 1296, ITM Model 1466, Plus SSIR, GDT Model 1194, ITM Model 1394, Plus DDDR, GDT Model 1298, ITM Model 1468, Plus DDDR, GDT Model 1297, ITM Model 1467

Guidant Corporation

St. Paul, MN

55112

Approval for the INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemaker System. The INSIGNIA I/ NEXUS I Entra and Plus Implantable Pacemakers are indicated for treatment of the following: 1) Symptomatic paroxysmal or permanent second- or third-degree AV block; 2) Symptomatic bilateral bundle branch block; 3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (e.g., sinus bradycardia, sinus arrest, sinoatrial [SA] block); 4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and 5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.

Adaptive-rate pacing is indicated for patients who may benefit from increased pacing rates concurrent with increases in MV and/or level of physical activity (INSIGNIA I Plus only). The INSIGNIA I Entra and Plus pacemakers’ dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual-Chamber modes are specifically indicated for treatment of the following: 1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block 2) VVI intolerance (e.g., pacemaker syndrome) in the presence of persistent sinus rhythm.

P970003/S038

3/28/02

Real-Time

NeuroCybernetic Prosthesis (NCP®) System, Model, 250 Programming Software, Versions 4.6 and 6.1

Cyberonics, Inc.

Houston, TX

77058

Approval for modifications to the existing Model 250 Programming Software, resulting in new Versions 4.6 and 6.1.

P970012/S013

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P970035/S031

3/1/02

180-Day

Medtronic AVE S7 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval to update the Medtronic AVE S7 with Discrete Technology Over-the-Wire and Rapid Exchange Coronary Stent System labeling to include 6-month post-procedure results for the study population.

P970051/S019

3/21/02

180-Day

Nucleus 24 Cochlear Implant System for Adults and Children with ESPrit3G Behind-the-Ear Speech Processor

Cochlear Americas

Englewood, CO

80112

Approval for the SP-10 Behind-the-Ear Speech Processor with ACE, CIS and SPEAK speech coding strategies. The device, as modified, will be marketed under the trade name ESPrit3G and is intended to be used with the CI24M, CI24R(ST) and CI24R(CS) cochlear implants.

P980016/S023

3/1/02

180-Day

Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™ DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System with Model 9966 (Marquis™ DR) Application Software, Model 9990 Desktop Software, Model 9322 Patient Magnet, and Model 9767/9767L Telemetry Programming Head (Telemetry B). The device, as modified, will be marketed under the trade name Medtronic Model 7274 Marquis™ DR Dual Chamber Implantable Cardioverter Defibrillator System and is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P980016/S027

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P980023/S006

3/11/02

Real-Time

Belos VR Implantable Cardioverter Defibrillator (ICD) System and Programmer Software Cartridge I-K01.0.A/4

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for programmer software cartridge I-K01.0.A/4, minor embedded software changes, minor hardware changes, and a correction to the "Use Before" date.

P980035/S021

3/18/02

180-Day

Medtronic Kappa 700 Series Pulse Generator (selected models)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for an alternate manufacturing facility located at Medtronic Arizona Device Manufacturing, Tempe, Arizona.

P980035/S022

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P980035/S023

3/15/02

Special

Medtronic Kappa 700/600 Models: KVDD701, KDR721, KDR731, KDR733 and Medtronic Kappa 900/800 Models: KVDD901, KDR921, KDR931, KDR933

Medtronic, Inc.

Minneapolis, MN

55432

Approval for two changes in the manufacturing process involving the epoxy dispense program and the wire bond loop program.

P980050/S012

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P980052/S001

3/1/02

180-Day

TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System

TMJ Concepts

Camarillo, CA

93012

Approval for a manufacturing site located at TMJ Concepts, Ventura, California.

P990001/S009

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P990016/S002

3/28/02

180-Day

McCue CUBA Clinical Ultrasonic Bone Sonometry System

McCue Corporation, Inc.

Winchester, UK

SO21-2AS

Approval of the CUBAClinical Data Controller (Data Controller). The Data Controller is a hand-held control device that enables the user to operate the CUBAClinical without the computer and the software for data analysis. The modifications to the Bone Sonometer consist of the integration of the Data Controller and associated software, simple replacement of the CUBAClinical serial connector, and Data Controller operating instructions. The results are displayed on an LCD screen display and the printout shows a graphical display of patient data.

P990026/S011

3/21/02

180-Day

GlucoWatch®2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for modifications to the electrical hardware and software of the original GlucoWatch Automatic Glucose Biographer. The device, as modified, will be marketed under the trade name GlucoWatch®2 Biographer and is indicated for: The GlucoWatch®2 Biographer is a glucose monitoring device intended for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. This device is intended for use by patients at home and in healthcare facilities. The device is for prescription use only. The GlucoWatch®2 Biographer is intended for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. The GlucoWatch®2 Biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of Biographer results should be based on the trends and patterns seen with several sequential readings over time.

P990027/S005

3/13/02

180-Day

Technolas 217A Excimer Laser System

Bausch & Lomb, Inc.

San Dimas, CA

91773

Approval for a manufacturing facility located at Bausch & Lomb Technolas GmbH, Feldkirchen, Germany.

P990030/S003

3/14/02

180-Day

CoStasis®/ DynaStat™ Surgical Hemostats

Cohesion Technologies

Palo Alto, CA

94303

Approval of the urological exclusion from the "Indications for Use" statement. The device, as modified, will be marketed under the trade names CoStasis®/DynaStat™ Surgical Hemostat and is indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to the hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

P990034/S002

3/11/02

Real-Time

Medtronic® IsoMed® Model 8472 Fixed Rate Infusion System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for: 1) propellant change from CFC-114 to n-Butane; 2) capillary tubing adjustment as a result of change to n-Butane; and 3) updates to the Technical Manual.

P990038/S002

3/7/02

180-Day

DiaSorin ETI-MAK-2 PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for inclusion of the instrument reproducibility study in the package insert.

P990041/S001

3/7/02

180-Day

DiaSorin ETI-AB-EBK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for reproducibility studies using serum in the package insert.

P990042/S002

3/5/02

180-Day

DiaSorin ETI-AB-AUK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for inclusion of plasma reproducibility studies in the package insert.

P990043/S002

3/11/02

180-Day

DiaSorin ETI-EBK PLUS Assay

DiaSorin, Inc.

Saluggia, Italy

Approval for inclusion of the instrument reproducibility study in the package insert.

P990044/S001

3/6/02

180-Day

DiaSorin ETI-CORE-IGMK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for inclusion of reproducibility studies in the package insert.

P990045/S002

3/7/02

180-Day

DiaSorin ETI-AB-COREK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for inclusion of the instrument reproducibility study in the package insert.

P990055/S002

3/19/02

180-Day

Oncogene Science Complexed PSA Microtiter ELISA

Oncogene Science

Cambridge, MA

02142

Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name Oncogene Science Complexed PSA Microtiter ELISA and is indicated for the following: The Oncogene Science Complexed PSA Microtiter ELISA is an in vitro diagnostic assay intended to quantitatively measure Complexed PSA (cPSA) in human serum. This device is indicated for the measurement of serum cPSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. The Oncogene Science Complexed PSA Microtiter ELISA is further indicated for follow-up and monitoring of patients with prostate cancer. cPSA levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.

P990055/S003

3/13/02

180-Day

Complexed PSA Microtiter ELISA

Oncogene Science

Cambridge, MA

02142

Approval for manufacturing sites located at Bayer Diagnostics, Elkhart, Indiana and Oncogene Science, Cambridge, Massachusetts.

P000007/S002

3/26/02

180-Day

Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P

Edwards Lifesciences LLC

Irvine, CA

92614

Approval for the size 29 mm Prima Plus Stentless Bioprosthesis.

P000009/S003

3/11/02

Real-Time

Tachos DR Implantable Cardioverter Defibrillator (ICD) System and Programmer Software Cartridge I-KDR.0.U

Biotronik, Inc.

Lake Oswego, OR

97053

Approval for programmer software cartridge I-KDR.0.U, embedded software changes and minor hardware changes to the Tachos DR ICD.

P000011/S004

3/1/02

180-Day

Phosphorylcholine (PC) coated BiodivYsio™ OC stent premounted on the Over-the-Wire (OTW) delivery system (BiodivYsio™ OC OTW)

Biocompatibles Cardiovascular, Inc.

Andover, MA

01810

Approval for the BiodivYsio™ OC OTW in 11 mm, 15 mm, 18 mm, 22 mm and 28 mm stent lengths and 3.0 mm, 3.5 mm and 4.0 mm diameters. The device, as modified, will be marketed under the trade name BiodivYsio™ OC OTW and is indicated for: "use in subjects with symptomatic ischemic heart disease due to de novo native coronary artery lesions (length ≤ 25 mm) with a reference vessel diameter ranging from ≥ 3.0 mm to ≤4.0 mm and intended to improve coronary luminal diameter. Long-term outcome (beyond 6 months) for this implant is unknown at present."

P000018/S018

3/25/02

180-Day

Novoste™ 60 mm

Beta-Cath™ 5 Fr System

Novoste Corporation

Norcross, GA

30093

Approval for the Novoste™

Beta-Cath™ 60 mm 5 Fr System. The Novoste™

Beta-Cath™ 60 mm 5 Fr System is intended to deliver beta radiation to the site of successful percutaneous coronary intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions with injury areas up to 40 mm in a reference vessle diameter ranging from 2.7 mm to 4.0 mm.

P000036/S002

3/19/02

Special

DERMAGRAFT

Advanced Tissue Sciences, Inc.

La Jolla, CA

92037

Approval for a change in the Caution statement in the Directions for Use from "Do not use Dermagraft after the expiration date" to "Do not use Dermagraft after the expiration date indicated on the labeled unit carton."

P000037/S001

3/6/02

Panel

On-X® Prosthetic Heart Valve, Models ONXM and ONXMC

Medical Carbon Research Institute, LLC

Austin, TX

78754

Approval for the On-X® Prosthetic Heart Valve, Model ONXM in sizes 25 mm, 27/29 mm, 31/33 mm, and Model ONXMC in size 25/33 mm in the mitral position. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the mitral position.

P000039/S001

3/27/02

180-Day

AMPLATZER® Septal Occluder (ASO) Device

AGA Medical Corporation

Golden Valley, MN

55427

Approval for the post-approval study protocol for the AMPLATZER® Septal Occluder (ASO) Device.

P010015/S006

3/13/02

180-Day

Medtronic/Vitatron CareLink Programmer Model 2090

Medtronic, Inc.

Minneapolis, MN

55432

P010030/S002

3/20/02

Real-Time

LifeVest™ (formerly (WCD®) 2000 System)

Lifecor, Inc.

Pittsburgh, PA

15238

Approval for a new trade name for the WCD® device. The device, as modified, will be marketed under the trade name LifeVest™ and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE OF APPROVAL	DEVICE TRADE NAME	COMPANY NAME, CITY, STATE AND ZIP	DEVICE DESCRIPTION / INDICATIONS
N18-286/S013 3/20/02	Gelfoam Absorbable Gelatin Sponge and Gelfilm Sterile Film	Pharmacia & Upjohn Kalamazoo, MI 49001	Change to the bacterial endotoxin test method for Gelfoam Absorbable Gelatin Sponge and Gelfilm Sterile Film in order to comply with the recently harmonized USP, EP and JP compendia for Bacterial Endotoxin Assay.
P950034/S021 3/26/02	Seprafilm® Adhesion Barrier	Genzyme Corporation Cambridge, MA 02139	Manufacturing change to replace the current manual cleaning process for removing residual manufacturing materials from equipment with a semi-automatic substrate washer. The semi-automatic substrate washer would decrease the time and labor used in the manufacturing cleaning process.
P980016/S026 3/28/02	Marquis DR ICD	Medtronic, Inc. Minneapolis, MN 55432	Change in the controlled environmental area from Class 10,000 to a minimum of Class 100,000.

APPLICATION NUMBER / DATE OF APPROVAL

DEVICE TRADE NAME

COMPANY NAME, CITY, STATE AND ZIP

DEVICE DESCRIPTION / INDICATIONS

N18-286/S013

3/20/02

Gelfoam Absorbable Gelatin Sponge and Gelfilm Sterile Film

Pharmacia & Upjohn

Kalamazoo, MI

49001

Change to the bacterial endotoxin test method for Gelfoam Absorbable Gelatin Sponge and Gelfilm Sterile Film in order to comply with the recently harmonized USP, EP and JP compendia for Bacterial Endotoxin Assay.

P950034/S021

3/26/02

Seprafilm® Adhesion Barrier

Genzyme Corporation

Cambridge, MA

02139

Manufacturing change to replace the current manual cleaning process for removing residual manufacturing materials from equipment with a semi-automatic substrate washer. The semi-automatic substrate washer would decrease the time and labor used in the manufacturing cleaning process.

P980016/S026

3/28/02

Marquis DR ICD

Medtronic, Inc.

Minneapolis, MN

55432

Change in the controlled environmental area from Class 10,000 to a minimum of Class 100,000.

Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 59

Summary of PMA Originals Under Review
Total Under Review: 62
Total Active: 31
Total On Hold: 31
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 260
Total Active: 161
Total On Hold: 99
Number Greater Than 180 Days: 5

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 59
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 75.9
FDA Time: 72.4 Days
MFR Time: 3.5 Days

PMA Final Decisions Rendered for March 2002

PMA Original Approvals

PMA Supplemental Approvals

30-Day Notices (135 Day Supplement was not required)