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. 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
| P040036 8/11/06 |
NaviStar™ ThermoCool® Deflectable Diagnostic/Ablation Catheter | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for the NaviStar™ ThermoCool® Deflectable Diagnostic/Ablation Catheters which include models N175TBH, N175TCH, N175TDH, N175TFH, N175TCBH, N175TCCH, N175TCDH, N175TCFH, and N175TCJH. The NaviStar™ ThermoCool® Diagnostic/Ablation Deflectable Tip Catheter and related accessory devices, when used with the Stockert 70 Radiofrequency (RF) Generator, are indicated for the treatment of recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults. The NaviStar™ ThermoCool® catheter provides location information when used with the Carto EP / XP Navigation System, and can be used for catheter-based cardiac electrophysiological mapping (stimulation and recording). |
| P050006 8/11/06 |
GORE HELEX™ Septal Occluder | W.L. Gore & Associated, Inc. Flagstaff , AZ 86001 |
Approval for the GORE HELEX™ Septal Occluder. The device is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closer of ostium secundum atrial septal defects (ASDs). |
| P050010 8/14/06 |
PRODISC®-L Total Disc Replacement | Synthes Spine Co., L.P. West Chester , PA 19380 |
Approval for the PRODISC®-L Total Disc Replacement. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (DDD) at one level from L3-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level. Patients receiving the PRODISC®-L Total Disc Replacement should have failed at least six months of conservative treatment prior to implantation of the PRODISC®-L Total Disc Replacement. |
| P050023 8/10/06 |
Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000 PLUS and Corox OTW Steroid Lead | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the Tupos LV/ATx CRT-D, Kronos LV-T CRT-D, 505.U Programmer Software for the ICS 3000, A-K00.7.U Programmer Software for the EPR/TMS 1000 PLUS and Corox OTW Steroid Lead. The Tupos LV/ATx and Kronos LV-T CRT-Ds are indicated for use in patients with all of the following conditions: 1) indicated for ICD therapy; 2) receiving optimized and stable Congestive Heart Failure (CHF) drug therapy; 3) symptomatic CHF (NYHA Class III/IV and LVEF ≤35%); and 4) intraventricular conduction delay (QRS duration ≥130 ms). The Tupos LV/ATx is also indicated for patients who, in addition to an indication for a CRT-D device, have atrial tachyarrhythmias or are at risk of developing atrial tachyarrhythmias. The Corox OTW Steroid leads are intended for implantation via the coronary veins to provide long term cardiac pacing when used in conjunction with a compatible pulse generator. |
| P050048 8/25/06 |
MONOLISA™ Anti-HBs EIA and MONOLISA™ Anti-HBs Calibrator Kit | Bio-Rad Laboratories Redmond , WA 98052 |
Approval for the MONOLISA™ Anti-HBs EIA and the MONOLISA™ Anti-HBs Calibrator Kit. The devices are indicated for: The MONOLISA™ Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody to hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. The MONOLISA™ Anti-HBs Calibrator Kit is intended for quantitative determination of anti-HBs in human serum and EDTA or citrated plasma. The MONOLISA™ Anti-HBs Calibrator Kit is to be used only with the MONOLISA™ Anti-HBs EIA. |
| P060003 8/7/06 |
AxSYM® AUSAB® | Abbott Laboratories, Abbott Park , IL 60064 |
Approval for the AxSYM® AUSAB® Assay. The device is indicated for: AxSYM® AUSAB® Reagent Pack is a microparticle enzyme immunoassay (MEIA) intended for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in sodium heparin). The assay is used for the quantitative measurement of antibody response to hepatitis B virus (HBV) vaccination for the determination of HBV immune status, and for the diagnosis of HBV disease associated with HBV infection when used in conjunction with other laboratory results and clinical information. The AxSYM ® AUSAB ® Standard Calibrators are used for the calibration of the AxSYM System when the system is used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) using the AxSYM AUSAB Reagent Pack. The performance of the AxSYM AUSAB Standard Calibrators has not been established with any other anti-HBs assays. The AxSYM ® AUSAB ® Controls are used for monitoring the performance of the AxSYM System (reagent, calibrators, and instrument) when used for the quantitative determination of antibody to hepatitis B surface antigen (anti-HBs) when using the AxSYM AUSAB Reagent Pack. The performance of the AxSYM AUSAB Controls has not been established with any other anti-HBs assays. |
| P060004 8/11/06 |
MEL 80™ Excimer Laser System | Carl Zeiss Meditec, Inc. Dublin , CA 94568 |
Approval for the MEL 80™ Excimer Laser System. The device uses an optical zone of 6.0 to 7.0 mm in diameter and a transition zone of 1.7 to 1.9 mm for total ablation diameter of 7.7 to 8.9 mm, and is indicated for primary Laser Assisted in situ Keratomileusis (LASIK) treatments for: 1) the reduction or elimination of myopia of less than or equal to -7.0 D, with or without refractive astigmatism of less than or equal to -3.0 D, with a maximum MRSE of -7.00 D; 2) in patients who are 21 years of age or older; 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of <=0.5D. |
| P060009 8/25/06 |
AxSYM CORE-M™ 2.0 and AxSYM CORE-M™ 2.0 Controls | Abbott Laboratories, Abbott Park , IL 60064 |
Approval for the Abbott AxSYM CORE-M™ 2.0 and AxSYM CORE-M™ 2.0 Controls. These devices are indicated for: The AxSYM CORE-M™ 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the in vitro qualitative detection of IgM antibody to hepatitis B virus core antigen (IgM anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). The assay is used as an aid in the diagnosis of acute or recent hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. The AxSYM CORE-M ™ 2.0 Controls are used for monitoring the performance of the AxSYM ® System (reagent and instrument) when used for the qualitative detection of IgM antibody to hepatitis B virus core antigen (IgM anti‑HBc) when using the AxSYM CORE-M™ 2.0 Reagent Pack. The performance of the AxSYM CORE-M™ 2.0 Controls has not been established with any other anti-HBc assays. |
PMA Supplemental Approvals
| P810031/S027 8/28/06 Real-Time |
Healon®, HealonGV® and Healon5® Sodium Hyaluronate Ophthalmic Viscoelastic Devices | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval for a new secondary packaging configuration for the Healon®, HealonGV® and Healon5® sodium hyaluronate ophthalmic viscoelastic devices. |
| P820003/S077 8/30/06 180-Day |
Various Families of Pacemakers | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Approval for a manufacturing site at Technical Services for Electronics, Inc., Arlington, Minnesota. |
| P890003/S098 8/30/06 180-Day |
Various Families of Pacemakers | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Approval for a manufacturing site at Technical Services for Electronics, Inc., Arlington, Minnesota. |
| P890003/S102 8/31/06 Real-Time |
Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD Devices | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Approval for the Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD devices. |
| P890003/S106 8/24/06 Real-Time |
Medtronic CareLink Monitor Model 2490H Version A07801 Revision C | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic CareLink Monitor Model 2490H Version A07801 Revision C. |
| P890003/S107 8/31/06 Real-Time |
All Pacemaker Models | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Longevity Projection Update SW v1.1. |
| P910001/S025 8/2/06 Real-Time |
CVX-300 Excimer Laser Version V3.7.12/V3.8.12 | The Spectranetics Corporation Colorado Springs , CO 80907 |
Approval for a new software version to the CVX-3000 Excimer Laser and revised labeling to the laser console. |
| P910077/S061 8/8/06 180-Day |
LATITUDE Patient Management System Model 6481 Inductive Communicator & Software v1.2.0 and Regulated Application Server (RAS) v2.0.3 | Guidant Corporation St. Paul , MN 55112 |
Approval for the LATITUDE Patient Management System Model 6481 Inductive Communicator & Software v1.2.0 and Regulated Application Server (RAS) v2.0.3. |
| P940031/S055 8/25/06 180-Day |
DISCOVERY, MERIDIAN Pacemaker Systems | Guidant Corporation CRM St. Paul , MN 55112 |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
| P950005/S019 8/29/06 180-Day |
Celsius DS and Celsius II Bi-Directional Diagnostic/Ablation Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for using a new handle and puller wires. |
| P960040/S118 8/9/06 135-Day |
VITALITY Implantable Cardioverter Defibrillators | Guidant Corporation St. Paul , MN 55112 |
Approval to include circuit board preparation to the Clonmel, Ireland facility. |
| P960040/S126 8/8/06 180-Day |
CONTAK and RENEWAL Families | Guidant Corporation St. Paul , MN 55112 |
Approval for the LATITUDE Patient Management System Model 6481 Inductive Communicator & Software v1.2.0 and Regulated Application Server (RAS) v2.0.3. |
| P960040/S127 8/25/06 180-Day |
PRIZM, PRIZM HE, PRIZM 2, VITALITY, VITALITY 2, VITALITY AVT, VITALITY DS, VITALITY EL, VITALITY HE Defibrillator Systems | Guidant Corporation CRM St. Paul , MN 55112 |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
| P960042/S009 8/2/06 Real-Time |
CVX-300 Excimer Laser Version V3.7.12/V3.8.12 | The Spectranetics Corporation Colorado Springs , CO 80907 |
Approval for a new software version to the CVX-3000 Excimer Laser and revised labeling to the laser console. |
| P960043/S059 8/8/06 Special |
Perclose A-T Suture Mediated Closure (SMC) System | Abbott Vascular, Inc. Redwood City , CA 94063 |
Approval for changes to the Instructions for Use (IFU) for the Perclose A-T Suture Mediated Closure (SMC) System. |
| P960058/S049 8/17/06 180-Day |
Harmony HiResolution Bionic Ear System | Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for a modification to the Soundwave™ Professional Suite software (Soundwave Version 1.4) which implements an optional feature, known as Fidelity 120, and adds support for the Auria Harmony Sound Processor. The software, as modified, will be marketed under the trade name SoundWave™ Professional Suite Version 1.4 and is indicated for adult patients and pediatric patients aged 12-months through 17 years, 11-months. However, the optional software capability known as Fidelity 120 (speech encoding strategy) is limited for use in adults with 1) post-lingual onset of severe or profound hearing loss, 2) a minimum of three-months experience with standard HiRes, and 3) who have the cognitive ability to choose the sound processing options. |
| P970003/S069 8/9/06 180-Day |
VNS Therapy System | Cyberonics Houston , TX 77058 |
Approval of the post-approval protocol revision for the device. |
| D970003/S073 8/25/06 180-Day |
PULSAR, PULSAR MAX, PULSAR MAX II, INSIGNIA Plus/Entra/Ultra, DISCOVERY II Pacemaker Systems | Guidant Corporation CRM St. Paul , MN 55112 |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
| P970004/S037 8/31/06 180-Day |
Medtronic InterStim Therapy for Urinary Control | Medtronic, Inc. Shoreview , MN 55126 |
Approval for labeling changes to incorporation results from the five year post approval study. |
| P970012/S024 8/31/06 Real-Time |
All Pacemaker Models | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Longevity Projection Update SW v1.1. |
| P970031/S015 8/28/06 180-Day |
Freestyle® Aortic Root Bioprosthesis, Model 995 | Medtronic Heart Valves, Inc. Santa Ana , CA 92705 |
Approval for changes to the instructions for use (IFU) based on the results of the completed post-market study for the device. |
| P980016/S073 8/31/06 Real-Time |
Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD devices. |
| P980016/S081 8/31/06 Real-Time |
Concerto Model C154DWK Implantable Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for updates to the D273 and L356 ICs. |
| P980035/S058 8/24/06 Real-Time |
Medtronic CareLink Monitor Model 2490H Version A07801 Revision C | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic CareLink Monitor Model 2490H Version A07801 Revision C. |
| P980035/S059 8/31/06 Real-Time |
All Pacemaker Models | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Longevity Projection Update SW v1.1. |
| P990056/S003 8/10/06 180-Day |
Elecsys Total PSA Immunoassay and Elecsys Total PSA CalSet | Roche Diagnostic Corporation Indianapolis , IN 46250 |
Approval for formulation change to the HAMA interference reduction proteins to improve assay robustness with regard to potential HAMA interference for the Elecsys total PSA Immunoassay and changes in matrix, antigen and Calibrator 1 target value for the Elecsys total PSA CalSet. The Elecsys total PSA CalSet, as modified, will be marketed under the trade name, Elecsys total PSA CalSet II. |
| P990064/S015 8/25/06 180-Day |
Mosaic® Porcine Bioprosthesis, Models 305 and 310 | Medtronic Heart Valves, Inc. Santa Ana , CA 92705 |
Approval for changes to the instructions for use (IFU) based on the results of the completed post-market study of the device. |
| P000032/S020 8/15/06 135-Day |
Her Option™ Cryoablation Therapy System | American Medical Systems Minnetonka , MN 55343 |
Approval for a change in adhesive formulation used to bond the thermocouple and heater wires for the device. |
| P000040/S007 8/18/06 180-Day |
HTA™ System | Boston Scientific Corporation Marlborough , MA 01752 |
Approval for modifications to the HTA Procedure Set. |
| P010012/S121 8/9/06 135-Day |
CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillators | Guidant Corporation St. Paul , MN 55112 |
Approval to include circuit board preparation to the Clonmel, Ireland facility. |
| P010012/S130 8/8/06 180-Day |
PRIZM and VITALITY Families | Guidant Corporation St. Paul , MN 55112 |
Approval for the LATITUDE Patient Management System Model 6481 Inductive Communicator & Software v1.2.0 and Regulated Application Server (RAS) v2.0.3. |
| P010012/S131 8/25/06 180-Day |
CONTAK RENEWAL, CONTAK RENEWAL 3, CONTAK RENEWAL 3 RF Cardiac Resynchronization Therapy Defibrillator Systems | Guidant Corporation CRM St. Paul , MN 55112 |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
| P010015/S024 8/31/06 Real-Time |
All Pacemaker Models | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Longevity Projection Update SW v1.1. |
| P010031/S040 8/31/06 Real-Time |
Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Medtronic CareLink Monitor Model 2490C and Model 2491 DMA Software to Support the Concerto CRT-D and Virtuoso ICD devices. |
| P010031/S048 8/31/06 Real-Time |
Virtuoso Models D154AWG/ D154VWC Implantable Devices | Medtronic, Inc. Shoreview , MN 55126 |
Approval for updates to the D273 and L356 ICs. |
| P010068/S006 8/29/06 180-Day |
Navistar DS and Navistar 4mm Bi-Directional Diagnostic/Ablation Catheters | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for using a new handle, puller wires and 1 mm location sensor. |
| P020003/S004 8/23/06 135-Day |
Coloplast Saline-Filled Testicular Prosthesis | Coloplast Corp. Santa Barbara , CA 93111 |
Approval to add black ink to improve the visibility of the serial numbers. |
| P020026/S025 8/25/06 180-Day |
Cypher® Sirolimus-Eluting Coronary Stent System | Cordis Corporation Miami Lakes , FL 33014 |
Approval to eliminate the commitment to implement/conduct elution methodology (current method 10116481) and specifications. |
| P030005/S035 8/25/06 180-Day |
CONTAK TR Cardiac Resynchronization Therapy Systems | Guidant Corporation CRM St. Paul , MN 55112 |
Approval for product reliability test to be added to the physician and patient labeling as well as other minor changes to the patient manuals. |
| P030006/S011 8/10/06 Real-Time |
Celsion Prolieve™ Thermodilatation System | Celsion Corporation Columbia , MD 21046 |
Approval for manufacturing changes to correct the inner manifold bond of the catheter and to confirm dimensions of tubing used with the heat exchanger. |
| P040001/S002 8/8/06 180-Day |
X STOP® Interspinous Process Decompression System | St. Francis Medical Technology Alameda , CA 94501 |
Approval for the X STOP pk , a modified version of the X STOP that includes a PEEK spacer and additional 16 mm spacer size. The device, as modified, will be marketed under the trade name X STOP pk and is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with x-ray, MRI, and/or CT evidence of thickening ligamentum flavum, narrowed lateral recess and/or central conal narrowing). The X STOP pk is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X STOPpk may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels. |
| P040013/S005 8/21/06 Real-Time |
GEM 21S® (Growth-Factor Enhanced Matrix) | BioMimetics Therapeutics, Inc. Franklin , TN 37067 |
Approval for the BMPI Sterility test Method to extend the expiry date to 36 months and is indicated to treat the following periodontally related defects: 1) Intrabony periodontal defects; 2) Furcation periodontal defects; and 3) Gingival recession associated with periodontal defects. |
| P040021/S001 8/3/06 180-Day |
St. Jude Medical Biocor Valve and Biocor Supra Valve | St. Jude Medical, Inc. St. Paul , MN 55117 |
Approval of the post-approval study protocol for the device. |
| P040034/S004 8/2/06 180-Day |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham , MA 02451 |
Approval for: 1) use of NOF Corporation as an alternate vendor for functionalizing raw PEG-polyol material to PEG-SG for use in the DuraSeal® Dural Sealant product, and 2) implementation of an in-process particle size inspection step prior to the milling step. |
| P050012/S002 8/21/06 Real-Time |
DexCom STS System | DexCom, Inc. San Diego , CA 92121 |
Approval for design revisions to the accessory software program to enable it to be used for consumer use. The software program, as modified will be marketed under the trade name DexCom DM-Consumer and is indicated for use by consumers to allow for the transfer of glucose data stored by the DexCom STS System into a personal computer. |
| P050042/S001 8/14/06 135-Day |
ARCHITECT® Anti-HCV Reagent Kits, ARCHITECT® Anti-HCV Calibrators, and ARCHITECT® Anti-HCV controls | Abbott Laboratories Abbott Park , IL 60064 |
Approval for the addition of a test method to detect changes between the bulk and the master lot (customer release) testing stages. |
| P050051/S001 8/7/06 135-Day |
ARCHITECT® AUSAB® Reagent Kit, ARCHITECT® AUSAB® Calibrators, ARCHITECT® AUSAB® Controls |
Abbott Laboratories Abbott Park , IL 60064 |
Approval for the addition of a test method to detect changes between the bulk and the master lot (customer release) testing stages. |
30-Day Notices (135 Day Supplement was not required)
| P810025/S026 8/24/06 |
Amvisc and Amvisc Plus | Bausch and Lomb, Inc. Dan Dimas, CA 9173 |
Change of the sterilization filter. |
| P810032/S052 8/24/06 |
PMMA Multi-Piece Posterior Chamber VS100 IOLS | Alcon Research LTD. Fort. Worth, TX 76134 |
New sterilizer for production use. |
| P830045/S101 8/9/06 |
Paragon Phoenix Multilog & Sensorithm Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P840060/S030 8/24/06 |
PMMA Single-Piece Posterior Chamber IOLS | Alcon Research LTD. Fort. Worth, TX 76134 |
New sterilizer for production use. |
| P880006/S044 8/9/06 |
Sensolog Model 703 Pulse Generator & P700 Programmer | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P880086/S124 8/9/06 |
Synchrony Model 2020T Pulse Generator | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P880086/S125 8/16/06 |
Affinity, Integrity, and Identity Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Software changes to the Downloader and Test System Software for the above listed devices. |
| P880087/S012 8/24/06 |
PMMA Anterior Chamber IOLS | Alcon Research LTD. Fort. Worth, TX 76134 |
New sterilizer for production use. |
| P910023/S114 8/9/06 |
Cadence® Tiered Therapy Defibrillation System | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P930014/S018 8/24/06 |
Acrysof Intraocular Lenses (IOLS) | Alcon Research LTD. Fort. Worth, TX 76134 |
New sterilizer for production use. |
| P950020/S018 8/22/06 |
Flextome™ Cutting Balloon™ Monorail Device | Boston Scientific San Diego , CA 02123 |
Change to make the mid-shaft of the catheter more robust to tensile failure. |
| D970012/S031 8/17/06 |
Inflatable Penile Prosthesis Model 700 | American Medical Systems Minnetonka , MN 55343 |
Change to combine the bonding process from two to one step for the Inflatable Penile Prosthesis Model 700. |
| P970013/S011 8/9/06 |
Microny SR + Model 2425T Pulse Generator | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P980016/S077 8/16/06 |
EnTrust and Virtuoso ICDs | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes in method of manufacture for contacts on several components and changes to the weld strength test method. |
| P980016/S078 8/17/06 |
EnTrust and Virtuoso ICDs | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes to the battery fill port to case laser sub-assembly weld process. |
| P980016/S080 8/17/06 |
EnTrust and Virtuoso ICDs | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes to the laser seam weld process. |
| P980044/S004 8/25/06 |
SUPARTZ® | Seikagaku Corporation Memphis , TN 38116 |
Increase in the sampling volume for the measurement of airborne bacteria and an increase in the sampling volume for the measurement of product osmotic pressure. |
| P000046/S014 8/24/06 |
Staarvisc™ II and Shellgel™ Sodium Hyaluronate | Anika Therapeutics, Inc. Woburn , MA 01801 |
A sterilization filter change. |
| P010031/S045 8/16/06 |
Concerto CRT-D | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes in method of manufacture for contacts on several components and changes to the weld strength test method. |
| P010031/S046 8/17/06 |
Concerto CRT-D | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes to the battery fill port to case laser sub-assembly weld process. |
| P010031/S047 8/17/06 |
Concerto CRT-D | Medtronic, Inc. Cardiac Rhythm Management Shoreview , MN 55126 |
Changes to the laser seam weld process. |
| P030009/S005 8/17/06 |
Micro-Driver Over-the-Wire Coronary Stent System and the Micro-Driver MX2 Coronary Stent System |
Medtronic Vascular Santa Rosa , CA 95403 |
Qualification and transfer of ring tumble and annealing processes to Brunk Industries. |
| P030019/S010 8/9/06 |
Orthovisc High Molecular Weight Hyaluronan | Anika Therapeutics, Inc. Woburn , MA 01801 |
Change in vent filter type use in the manufacture of the device. |
| P030035/S017 8/9/06 |
Frontier Biventricular Cardiac Pacing System | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P030035/S018 8/16/06 |
Frontier II Biventricular Pacing Systems | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Software changes to the Downloader and Test System Software for the above listed devices. |
| P030054/S033 8/9/06 |
Epic HF System | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Change to an automated selective soldering process as an alternate method for the soldering on the Pepin board of the Model 3650 Merlin PCS. |
| P040012/S022 8/17/06 |
ACCULINK and RX ACCULINK Carotid Stent System | Abbott Vascular Vascular Solutions Santa Clara , CA 95054 |
Addition of a semi-automated process to the available techniques for non-tapered stent expansion. |
| P040020/S002 8/24/06 |
Acrysof Restor Apodized Diffractive IOLS | Alcon Research LTD. Fort. Worth, TX 76134 |
New sterilizer for production use. |
Summary of PMA Originals & Supplements Approved
Originals: 8
Supplements: 46
Summary of PMA Originals Under Review
Total Under Review: 85
Total Active: 31
Total On Hold: 54
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 397
Total Active: 175
Total On Hold: 222
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 0
Supplements: 91
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 46
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 117.5
FDA Time: 95.5 Days MFR Time: 22.0 Days
Updated October 13, 2006
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