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.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P050019 10/23/08 |
Carotid WALLSTENT® Monorail® Endoprosthesis | Boston Scientific Corporation Mountain View, CA 94043 |
Approval for the Carotid WALLSTENT® Monorail® Endoprosthesis. The device, used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below: 1) Patients with neurological symptoms and > 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, and; 2) Patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. |
| P050029 10/10/08 |
Helios II Ablation Catheter | Stereotaxis, Inc. St. Louis, MO 63108 |
Approval for the Helios II Ablation Catheter. The Helios II® Ablation Catheter is intended for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat patients with supraventricular (SVT) tachycardias. It is intended to eliminate atrioventricular reentrant tachycardia (AVRT) in patients with overt or concealed accessory pathways, to eliminate AV nodal re-entrant tachycardia (AVNRT), and to create complete AV nodal block in patients with difficult to control ventricular response to atrial fibrillation. The Helios II Ablation Catheter is intended for use with the Biosense Webster Stockert 70 RF Generator via a Biosense Webster cable model C6-MR10/MSTK-S (6 foot) or C10-MR10/MSTK-S (10 foot). The Helios II Ablation Catheter is for use only with the Stereotaxis Magnetic Navigation System (MNS) and is compatible with the Cardiodrive Catheter Advancement System (CAS). |
| P060008 10/10/08 |
TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System. The device is indicated for improving luminal diameter for the treatment of de novo lesions <= 28 mm in length in native coronary arteries >= 2.5 mm to <= 4.0 mm in diameter. |
| P060025 10/30/08 |
ATS 3f® Aortic Bioprosthesis | 3F Therapeutics, Inc. Lake Forest, CA 92630 |
Approval for the ATS 3F® Aortic Bioprosthesis, Model 1000 (sizes 21, 23, 25, 27 and 29 mm). The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves. |
| P060030 10/30/08 |
COBAS AmpliPrep/ COBAS TaqMan HCV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 95466 |
Approval for the COBAS Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus ribavirin. No information is available on the assay's predictive value when other therapies are used. Assay performance for determining the slate of HCV infection has not been established." |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S095 10/10/08 180-Day |
NC Sprinter RX Balloon Dilatation Catheter | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the NC Sprinter RX Balloon Dilatation Catheter. |
| P790017/S096 10/31/08 180-Day |
Sprinter Legend RX Balloon Dilatation Catheter | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter. The device, as modified, is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.25 mm – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents. Also, approval for a new manufacturing site at Medtronic Mexico, S. De R.L. De C.V., Baja California, Mexico. |
| P820003/S085 10/17/08 180-Day |
Model 5388 and Model 5348 External Pulse Generators | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for a manufacturing site located at Benchmark Electronics, Inc., Winona, Minnesota. |
| P830055/S104 10/10/08 Real-Time |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, Inc. 46581 |
Approval for modified LCS Total Knee System labeling and instrumentation to be used with BrainLAB computer-aided navigation software during surgical implantation of the LCS Total Knee System. |
| P840001/S118 10/17/08 135-Day |
Restore® Family of Neurostimulator Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of the Sterilization Automated Release or StAR System to the sterilization operation at the Medtronic Neuromodulation Sullivan Lake manufacturing facility. |
| P860004/S099 10/17/08 135-Day |
SyncroMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of the Sterilization Automated Release or StAR System to the sterilization operation at the Medtronic Neuromodulation Sullivan Lake manufacturing facility. |
| P860019/S227 10/8/08 Real-Time |
Quantum™ Maverick™ and OTW PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for modification to the proximal weld process. The device, as modified, will be marketed under the trade name Quantum Maverick Balloon Catheters and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Quantum Maverick Balloon Catheter (balloon models 2.0 mm – 5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. |
| P870072/S040 10/31/08 Real-Time |
Thoratec Implantation Ventricular Assist Device (IVAD) System | Thoratec Corporation Pleasanton, CA 94588 |
Approval to strengthen the IVAD Y-connector termination by adding a small amount (35 uL) of silicone oil to the inner wall of the pneumatic line to reduce the transferable force between the IVAD optical sensor cable and the pneumatic line wall. |
| P890003/S148 10/14/08 Real-Time |
CareLink Monitor Model 2490C, Model 2491 DDMA and CardioSight Reader Model 2020A | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval for an update (version 1.1) to software application Model SW007 for the Medtronic Carelink Programmer Model 2090. |
| P890003/S150 10/21/08 Real-Time |
CareLink Monitor Model 2490C, Model 2491 DDMA and CardioSight Reader Model 2020A | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval to implement a design change to use Models 2490C Medtronic Carelink Monitor, 2020A Cardiosight Reader, and 2491 Device Data Management Application (DDMA) to provide patients and data transfer for the Concerto II model CRT-D D274TRK, Virtuoso II ICD model DR D274DRG and model VR D274VRC devices. |
| P890055/S025 10/10/08 180-Day |
SureStream Intraspinal Catheter Kit (60-2918) & SureStream Replacement Connector and Strain Relief Sleeve (60-2950) | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for: 1) a new manufacturing facility, Codman Neurosciences, SARL, LeLocle, Switzerland and 2) the additional device accessories for the Codman 3000 Constant Flow Implantable Infusion Pump – SureStream Intraspinal Catheter Kit (60-2918) & SureStream Replacement Connector and Strain Relief Sleeve (60-2950). |
| P900056/S089 10/29/08 180-Day |
Rotablator™ Rotational Angioplasty System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Approval for 1) a manufacturing site located at Boston Scientific Corporation, Fremont, California; and 2) the addition of a vendor for console accessories. |
| P910073/S073 10/31/08 135-Day |
Reliance Family of Leads | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for additional inspection steps. |
| P960004/S041 10/9/08 Real-Time |
FINELINE II Sterox EZ Leads | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for modifications to the mannitol bullet forming fixture and lead tip protector for the device. |
| P960009/S055 10/17/08 135-Day |
Activa® Therapy for DBS™ | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of the Sterilization Automated Release or StAR System to the sterilization operation at the Medtronic Neuromodulation Sullivan Lake manufacturing facility. |
| P960030/S023 10/9/08 180-Day |
SJM IsoFlex Optim Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, LLC, Arecibo, Puerto Rico. |
| P960058/S066 10/15/08 135-Day |
HiResolution Bionic Ear System | Advanced Bionics Sylmar, CA 91342 |
Approval for an improved automated test system for the HiRes90K. |
| P970003/S099 10/9/08 135-Day |
VNS Therapy™ System Pulse Generator | Cyberonics, Inc. Houston, TX 77058 |
Approval for sterilization of mixed loads. |
| P970004/S060 10/17/08 135-Day |
InterStim® Sacral Nerve Stimulation System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of the Sterilization Automated Release or StAR System to the sterilization operation at the Medtronic Neuromodulation Sullivan Lake manufacturing facility. |
| P980016/S132 10/1/08 180-Day |
Medtronic Model 2696 InCheck® Patient Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Plexus Services Corp., Plexus-Penang, Penang, Malaysia, for the testing, labeling and packaging of the device. |
| P980016/S150 10/24/08 180-Day |
Marquis DR/VR ICD (7274, 7230) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the RV Lead Integrity Alert (RVLIA) feature and Model SW012, Version 1.1, RVLIA Software. |
| P980016/S157 10/23/08 Real-Time |
Virtuoso II ICD DR/VR; Models D154AWG, D154VWC | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval to implement a design change to add three new "intermediate-feature" models (Concerto II model CRT-D D274TRK. Virtuoso II ICD model DR D274DRG and model VR D274VRC) to the approved Gen 2 Consulta/Secura/ Maxima II family of devices (Consulta CRT-D D224TRK, Maximo II CRT-D D284TRK. Secure VR D224VRC, Maximo II DR D284DRG, and Maximo II D284 VRC submitted under P01003I/S084 and P980016/S114, approved March 17, 2008). |
| P980016/S158 10/21/08 Real-Time |
Virtuoso II ICD DR/VR Models D154AWG, D154VWC | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval to implement a design change to use Models 2490C Medtronic Carelink Monitor, 2020A Cardiosight Reader, and 2491 Device Data Management Application (DDMA) to provide patients and data transfer for the Concerto II model CRT-D D274TRK, Virtuoso II ICD model DR D274DRG and model VR D274VRC devices. |
| P980035/S098 10/1/08 180-Day |
Medtronic Model 2696 InCheck® Patient Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Plexus Services Corp., Plexus-Penang, Penang, Malaysia, for the testing, labeling and packaging of the device. |
| P980049/S039 10/9/08 Real-Time |
Isoline, Model 2CR | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for a change to the finished device acceptance criteria and an associated labeling change in the screw mechanism test for the Isoline products. |
| P980049/S040 10/31/08 180-Day |
Ovatio VR 6250 and Ovatio DR 6550 | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for a modification to the Automatic Sensitivity Control (ASC) Algorithm in the Ovatio VR 6250, Ovatio DR 6550 and Ovatio CRT 6750. |
| P990012/S006 10/30/08 180-Day |
Elecsys HBsAg Test System | Roche Professional Diagnostics Indianapolis, IN 46250 |
Approval to extend application of the Elecsys HBsAg and Elecsys Anti-HBs test systems onto the updated version of the Modular Analytics E170 analyzer known as the cobas e 601 analyzer. While the Modular Analytics modular system integrates the E170 module with clinical chemistry modules P or D, the cobas e 601 immunoassay analyzer is a component of the C6000 modular system which integrates immunology testing with the cobas c 501 clinical chemistry analyser. There have been no changes to the composition of any of te test system reagents (immunoassay, controls or confirmatory test), the application parameters, the analyzer’s analytical measuring component or how the results are calculated. The indications for use of the two test systems remain the same. |
| P990019/S005 10/10/08 180-Day |
4170 Blu-U Blue Light PDT Illuminator | DUSA Pharmaceuticals Wilmington, MA 01887 |
Approval for the National Biological Corp., Beachwood, Ohio facility, for contract manufacturing. |
| P990020/S033 10/16/08 180-Day |
AneuRx Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a manufacturing site located at Medtronic Ireland, Galway, Ireland. |
| P990034/S011 10/17/08 135-Day |
IsoMed® Pump and Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for the implementation of the Sterilization Automated Release or StAR System to the sterilization operation at the Medtronic Neuromodulation Sullivan Lake manufacturing facility. |
| P990048/S003 10/31/08 180-Day |
VISULAS 690 plus and VISULINK PDT/U Adapter | Carl Zeiss Meditec AG Jena, Germany 07745 |
Approval for changes to the laser controller; the addition of new user interface including touch-sensitive screen and rotary knobs; a new integrated power supply with micro-controller electronic components; new labeling; and new software (firmware). The device, as modified, will be marketed under the trade name VISULAS 690 plus and VISULINK PDT/U Adapter and is indicated for use in VISUDYNE™ therapy as sources of photoactivation of VISUDYNE™ (verteporfin for injection) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia. |
| P990056/S008 10/17/08 180-Day |
Elecsys® total PSA Test System on cobas® e 601 Immunoassay Analyzer | Roche Diagnostics Indianapolis, IN 46250 |
Approval for extension of the Elecsys® total PSA system onto updated model of the Modular Analytics E170 analyzer, known as the cobas® e 601 analyzer. |
| P990074/S020 10/24/08 180-Day |
Natrelle™ Saline-Filled Breast Implants | Allergan, Inc. Goleta, CA 93117 |
Approval for a manufacturing site located at the Global Park Facility, La Aurora de Heredia, Costa Rica, for the shell dipping/fabrication process. |
| P000025/S037 10/9/08 Special |
Med-El COMBI 40+ Cochlear Implant System | Med-El Corporation Durham, NC 27713 |
Approval for adding inspections for short circuits in the manufacturing of the SONATA and PULSAR implants. |
| P000027/S006 10/17/08 180-Day |
Elecsys® free PSA Test System on cobas® e 601 Immunoassay Analyzer | Roche Diagnostics Indianapolis, IN 46250 |
Approval for extension of the Elecsys® free PSA system onto updated model of the Modular Analytics E170 analyzer, known as the cobas® e 601 analyzer. |
| P000029/S051 10/22/08 Special |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for modification of the Deflux® Package Insert to minimize the incidence of syringe breakage and resulting treatment interruptions. |
| P010031/S101 10/1/08 180-Day |
Medtronic Model 2696 InCheck® Patient Assistant | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Plexus Services Corp., Plexus-Penang, Penang, Malaysia, for the testing, labeling and packaging of the device. |
| P010031/S125 10/23/08 Real-Time |
Concerto II CRT-D and Virtuoso II ICD DR/VR | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval to implement a design change to add three new "intermediate-feature" models (Concerto II model CRT-D D274TRK. Virtuoso II ICD model DR D274DRG and model VR D274VRC). |
| P010031/S126 10/21/08 Real-Time |
Concerto II CRT-D and Virtuoso II ICD DR/VR Models C154DWK, C164AWK | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval to implement a design change to use Models 2490C Medtronic Carelink Monitor, 2020A Cardiosight Reader, and 2491 Device Data Management Application (DDMA) to provide patients and data transfer for the Concerto II model CRT-D D274TRK, Virtuoso II ICD model DR D274DRG and model VR D274VRC devices. |
| P010033/S013 10/31/08 Real-Time |
QuantiFERON® - TB Gold-in-Tube | Cellestis, Inc. Valencia, CA 91355 |
Approval for the addition of QuantiFERON® blood collection tubes suitable for use at altitudes above 6,500 feet. |
| P010038/S015 10/9/08 180-Day |
Second Look® - Computer-Aided Detection System | iCAD, Inc. Nashua, NH 03062 |
Approval for a manufacturing site located at iCAD, Inc., Nashua, New Hampshire. |
| P010054/S008 10/30/08 180-Day |
Elecsys Anti-HBs Test System | Roche Professional Diagnostics Indianapolis, IN 46250 |
Approval to extend application of the Elecsys HBsAg and Elecsys Anti-HBs test systems onto the updated version of the Modular Analytics E170 analyzer known as the cobas e 601 analyzer. While the Modular Analytics modular system integrates the E170 module with clinical chemistry modules P or D, the cobas e 601 immunoassay analyzer is a component of the C6000 modular system which integrates immunology testing with the cobas c 501 clinical chemistry analyser. There have been no changes to the composition of any of te test system reagents (immunoassay, controls or confirmatory test), the application parameters, the analyzer’s analytical measuring component or how the results are calculated. The indications for use of the two test systems remain the same. |
| P020014/S019 10/8/08 180-Day |
Essure™ Contraceptive Tubal Occlusion Device and Delivery System | Conceptus, Inc. Mountain View, CA 94041 |
Approval for a contract sterilization site located at Sterigenics US, Inc., Santa Teresa, New Mexico. |
| P020026/S048 10/9/08 180-Day |
CYPHER™ Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER Stent) | Cordis Corporation Miami, FL 33102 |
Approval for final eluting specifications. |
| P020030/S004 10/17/08 135-Day |
Stelid II, Stelix, and Stelix II Steroid-Eluting Pacing Leads |
ELA Medical, Inc. Plymouth, MN 55441 |
Approval for a change involving alternate process parameters for the manufacturing of materials in the steroid collar components. |
| P030006/S018 10/16/08 135-Day |
Prolieve™ Thermodilitation System | Boston scientific Corporation Marlborough, MA 01752 |
Approval for the modifications to the Prolieve™ Heat Exchanger Cartridge assembly method. The device, as modified, will be marketed under the trade name Prolieve™ Thermodilitation System and is indicated for the treatment of symptomatic Benign Prostatic Hyperplasia (BPH) in men. |
| P030009/S020 10/22/08 180-Day |
Micro-Driver Rapid Exchange (RX) Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the addition of the Micro-Driver Rapid Exchange delivery platform and the addition of the Medtronic Mexico facility in Tijuana for the manufacturing of catheter sub-assemblies. The device, as modified, will be marketed under the trade name Micro-Driver Rapid Exchange (RX) Coronary Stent System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions with reference vessel diameters of 2.25 - 2.75 mm and ≤ 21 mm in length. Outcome beyond 270 days for this permanent implant is unknown at present. |
| P030017/S062 10/10/08 135-Day |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for modifying the assembly and manufacturing procedures for the Precision Connector M1. |
| P030036/S003 10/21/08 135-Day |
SelectSecure Lead Model 3830 | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a change to the 1 cc syringe used to manually measure application with a manually operated automated dispenser and to modify the dimensions of the filling tube to prevent over-fill of the precisely measured steroid solution within the filling tube. |
| P040002/S018 10/8/08 180-Day |
Powerlink System, 25mm, 28mm, and 34mm Suprarenal Bifurcated Stent Grafts and Accessories | Endologix, Inc. Irvine, CA 92618 |
Approval for suprarenal versions of the Powerlink bifurcated stent grafts and accessories. |
| P040002/S021 10/14/08 Real-Time |
Endologix PowerLink® System, Visiflex IS Delivery System | Endologix, Inc. Irvine, CA 92618 |
Approval for minor design and associated labeling changes to the Visiflex IS Delivery System, a component of the Endologix PowerLink® System. |
| P040005/S003 10/10/08 Real-Time |
HER2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for the following changes: 1. Labeling change in the Step 1 (pre-treatment) in the Instructions for Use to include an alternative method to heat the pre-treatment buffer using a microwave oven with boil sensor capability as "water bath" independently of the buffer start volume and temperature 2. Labeling change in the Step 2 (Pepsin, ready-to-use) in the Instructions for Use to include an alternative method of incubation with pepsin using a heating block, e.g. a Hybridizer, and incubation at 37°C as an alternative to incubation at room temperature 3. Changes in reagent volume and vial size for Vial 1 and Vial 2 4. Modification of signal counting guide to include under-digested nuclei 5. Labeling change in the Instructions for Use to include the Dako Hybridizer as an alternative to the use of heating block and hybridization oven for denaturation and hybridization steps, respectively. |
| P040033/S003 10/14/08 180-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Memphis, TN 38116 |
Approval for a manufacturing site located at Smith & Nephew Orthopaedics Ltd., Warwickshire, United Kingdom, to perform final machining, and a manufacturing site located at LPE Medical Ltd., Hampshire, United Kingdom. |
| P050010/S002 10/14/08 135-Day |
ProDisc-L Total Disc Replacement | Synthes Spine West Chester, PA 19380 |
Approval for changes to the milling feed rate and tool speed for processes for the ProDisc-L. |
| P050020/S004 10/8/08 180-Day |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Approval for the CoPilot health Management System to be used in an accessory data management system with the FreeStyle Navigator Continuous Glucose Monitoring System. |
| P060001/S006 10/8/08 180-Day |
Protégé GPS & Protégé RX Carotid Stent Systems | Ev3 Plymouth, MN 55442 |
Approval of the post-approval study. |
| P060002/S002 10/28/08 180-Day |
FLAIR™ Endovascular Stent Graft with Optimized Delivery System | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval for the Optimized Delivery System, the transfer of manufacturing of the delivery system to Angiomed GmbH & Co., Karlsruhe, Germany, and the transfer of sterilization to Bard Medical Division Regional Sterilization and Regional Sterilization Madison Operation, in Covington, Georgia, and Madison, Georgia, respectively. |
| P060027/S002 10/31/08 180-Day |
Ovatio Cardiac Resynchronization Therapy (CRT) Model 6750 | ELA Medical, Inc. Plymouth, MN 55441 |
Approval of the post-approval study. |
| P060027/S004 10/31/08 180-Day |
Ovatio CRT 6750 | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for a modification to the Automatic Sensitivity Control (ASC) Algorithm in the Ovatio VR 6250, Ovatio DR 6550 and Ovatio CRT 6750. |
| P060033/S001 10/2/08 180-Day |
Endeavor Zotarolimus-Eluting Coronary Stent on the Sprint Over-the-Wire, Sprint Rapid Exchange, or Sprint Multi-Exchange II Coronary Stent Systems |
Medtronic Vascular Santa Rosa, CA 95403 |
Approval for the Sprint delivery system family. |
| P070009/S003 10/15/08 180-Day |
REALIZE™ Adjustable Gastric Band | Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 |
Approval for a line extension to the REALIZE™ Adjustable Gastric Band The device, as modified, will be marketed under the trade name REALIZE™ Adjustable Gastric Band Curved (Model BD3XV) and is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m 2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P860057/S050 10/29/08 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves. |
| P870056/S030 10/29/08 |
Carpentier-Edwards Valved Conduit Bioprosthesis and Carpentier-Edwards Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves. |
| P870077/S029 10/29/08 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves. |
| P880086/S168 10/1/08 |
Affinity, Integrity, and Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of an End of Life (EL) communication software test to the automated manufacturing software test suite used during hybrid manufacturing. |
| P910073/S074 10/24/08 |
EasyTrak 3 | Guidant Corporation St. Paul, MN 55112 |
Change in the medical adhesive used in the lead adapter. |
| P910073/S076 10/17/08 |
Endotak Reliance Lead | Guidant Corporation St. Paul, MN 55112 |
Addition of an alternate supplier for the shocking coil components. |
| P920047/S038 10/10/08 |
SteeroCath T Cardiac Ablation Catheter | Boston Scientific Corporation San Jose, CA 95134 |
Change to the packaging process for the device. |
| P920048/S006 10/22/08 |
Rapid fFN for the TLi IQ System | Cytyc Corporation Sunnyvale, CA 94089 |
Alternative manufacturing process for the Rapid fFN Cassette. |
| P930014/S028 10/15/08 |
AcrySof® Single Piece Intraocular Lens | Alcon Research, Ltd. Fort Worth, TX 76134 |
Moving of the IOL final packaging and secondary labeling operations, with three (3) support functions, into the recently constructed new facility on the same property. |
| P950020/S030 10/1/08 |
Coronary Flextome Cutting Balloon Device | Boston Scientific Corporation San Diego, CA 92121 |
Addition of a step to an existing in-process inspection of the proximal balloon bond for all models of the device. |
| P950029/S038 10/17/08 |
Symphony Family, Rhapsody Family | ELA Medical, Inc. Plymouth, MN 55441 |
Change the welding energy measurement method from an indirect method to a direct energy measurement method. |
| P960058/S070 10/31/08 |
HiResolution Bionic Ear System | Advanced Bionics Sylmar, CA 91342 |
Use of an alternate component for the HiRes90K. |
| P970003/S101 10/28/08 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Change to the handheld rework process. |
| D970003/S102 10/10/08 |
INSIGNIA Pacemakers | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Change to automate the process of applying lubricant to pulse generator seal plugs. |
| P970012/S044 10/17/08 |
Kappa 400 DR and Kapapa 400 SR | Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| D970012/S057 10/9/08 |
AMS 700 Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Additional sterilization unit at the facility. |
| D970012/S058 10/29/08 |
AMS 700 Series Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Alternate manufacturing site at American Medical Systems, Inc., for the coating process. |
| P980016/S152 10/2/08 |
Maximo, Marquis, Intrinsic, and EnTrust Families of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Mounds View, MN 55112 |
Change to automate a manufacturing test for the devices. |
| P980016/S153 10/10/08 |
Marquis Family, Maximo Family, Intrinsic Family, Virtuoso Family and Maximo II DR/VR Family | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to perform wafer saw and die visual processing at the supplier. |
| P980016/S154 10/17/08 |
GEM II, Intrinsic 30/ Intrinsic, Marquis DR/VR, Maximo DR/VR, EnTrust, Virtuoso, Secura DR/VR and Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| P980016/S155 10/17/08 |
EnTrust, Virtuoso, Secura DR/VR and Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change the laser ribbon bonding manufacturing process. |
| P980016/S156 10/17/08 |
Secura ICD, Models D224DRG and D224VRC | Medtronic, Inc. Mounds View, MN 55112 |
Change in the assembly flow and the addition of a new piece of equipment. |
| P980022/S035 10/2/08 |
Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Change to the sterilization process of the glucose sensor’s adhesion patch. |
| P980022/S036 10/3/08 |
Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Change to the one-piece base needle tunnel geometry. |
| P980035/S115 10/10/08 |
EnRhythm IPG | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to perform wafer saw and die visual processing at the supplier. |
| P980035/S116 10/17/08 |
Adapta/Sensia/ Versa, EnRhythm, AT 500 Series, Kappa 700, Kappa 800/900, Sigma, Medtronic 350 Series, EnPulse E2 IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| P980035/S117 10/17/08 |
EnRythm IPG, Adapta/Versa, Sensia | Medtronic, Inc. Mounds View, MN 55112 |
Change the laser ribbon bonding manufacturing process. |
| P980049/S042 10/17/08 |
Ovatio VR/DR | ELA Medical, Inc. Plymouth, MN 55441 |
Change the welding energy measurement method from an indirect method to a direct energy measurement method. |
| P990001/S044 10/10/08 |
C-series and T-series Devices | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to perform wafer saw and die visual processing at the supplier. |
| P990001/S045 10/17/08 |
Clarity, Diamond 3, Jade 3, Ruby 3, Topaz 3, Vita 2 DDR, C-Series, and T-Series | Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| P990004/S15 10/3/08 |
SURGIFOAM Absorbable Gelatin Sponge | Johnson & Johnson Wound Management A Division of Ethicon, Inc. Somerville, NJ 08876 |
Elimination of sterility testing as part of the sterility release procedure. The results of bioburden testing and dry heat sterilization process parameters will continue to be reviewed as part of the sterility release. |
| P990009/S023 10/16/08 |
Floseal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Construction of an additional manufacturing suite. |
| P990009/S024 10/24/08 |
Floseal Endoscopic Applicator | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Additional cleaning procedure and inspection procedure at two (2) contract vendors and an inspection procedure at the Baxter manufacturing facility located n Irvine, California. |
| P990052/S021 10/24/08 |
Vibrant Soundbridge Middle Ear Implant System | MED-EL Corporation Durham, NC 27713 |
Addition of two clean-rooms at the Austria facility. |
| P000007/S018 10/29/08 |
Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves. |
| P000025/S038 10/24/08 |
COMBI 40+ Cochlear Implant System | MED-EL Corporation Durham, NC 27713 |
Addition of two clean-rooms at the Austria facility. |
| P000037/S014 10/9/08 |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78754 |
Introduction of a second D-Ox cleaning process. |
| P000037/S015 10/3/08 |
On-X Prosthetic Heart Valve | Medical Carbon Research Institute, LLC Austin, TX 78754 |
Revision to the software used to post-process dimensional measurement information. |
| P000053/S019 10/9/08 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Additional sterilization unit at the facility. |
| P010015/S053 10/17/08 |
InSync and InSync III |
Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| P010020/S011 10/9/08 |
Acticon Artificial Bowel Sphincter | American Medical Systems Minnetonka, MN 55343 |
Additional sterilization unit at the facility. |
| P010031/S120 10/2/08 |
InSync Sentry, InSync Maximo, InSync III Marquis, InSync II Marquis, InSync II Protect, and InSync II Protect Families of Cardiac Resynchronization Therapy Device and Defibrillators (CRT-Ds) | Medtronic, Inc. Mounds View, MN 55112 |
Change to automate a manufacturing test for the devices. |
| P010031/S121 10/10/08 |
InSync III Protect, InSync II Marquis Family, InSync III Marquis Family, InSync II Protect, InSync Sentry Family, InSync Maximo Family, Concerto, Consulta, Maximo II | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Change to perform wafer saw and die visual processing at the supplier. |
| P010031/S122 10/17/08 |
InSync ICD, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Maximo, InSync Sentry, InSync III Protect, Concerto, Consulta, and Maximo |
Medtronic, Inc. Mounds View, MN 55112 |
Change in equipment used for blister sealing process. |
| P010031/S123 10/17/08 |
Concerto, Consulta, Maximo II | Medtronic, Inc. Mounds View, MN 55112 |
Change the laser ribbon bonding manufacturing process. |
| P010031/S124 10/17/08 |
Consulta CR-D, Model D224TRK and Maximo II CRT-D, Model D284TRK | Medtronic, Inc. Mounds View, MN 55112 |
Change in the assembly flow and the addition of a new piece of equipment. |
| P010041/S017 10/29/08 |
Carpentier-Edwards Supraannular (S.A.V.) Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
Alternate supplier for gluteraldehyde used in the manufacture of tissue heart valves. |
| P020004/S037 10/3/08 |
Gore Excluder® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Addition of an automated film wrapping machine for the Excluder wrapped grafts and cuffs and TAG wrapped cuff. |
| P020036/S011 10/30/08 |
SMART® Nitinol Stent System and SMART® Control Nitinol Stent System for User in Iliac Arteries | Cordis Corporation Warren, NJ 07059 |
Change to the test method for a delivery system component used in the manufacture of the device. |
| P030017/S080 10/3/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Neuromodulation Sylmar, CA 91342 |
Modification to the Implantable Pulse Generator (IPG) vibration test process. |
| P030017/S086 10/15/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Neuromodulation Sylmar, CA 91342 |
Changes to the Implantable Pulse Generator assembly process. |
| P030017/S087 10/14/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Neuromodulation Sylmar, CA 91342 |
Change to the epoxy mixing process. |
| P030035/S047 10/1/08 |
Frontier and Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of an End of Life (EL) communication software test to the automated manufacturing software test suite used during hybrid manufacturing. |
| P030047/S015 10/30/08 |
PRECISE® Nitinol Stent System for Use in Carotid Arteries | Cordis Corporation Warren, NJ 07059 |
Change to the test method for a delivery system component used in the manufacture of the device. |
| P030054/S105 10/10/08 |
QuickFlex Family of Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate supplier of weld electrodes. |
| P040024/S028 10/22/08 |
Restylane Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Approval to perform a quality control test in-house that is now being performed by a contract laboratory. |
| P040024/S029 10/29/08 |
Restylane Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Use of a raw material from a new purification line and a new storage area. |
| P040043/S025 10/3/08 |
Gore TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Addition of an automated film wrapping machine for the Excluder wrapped grafts and cuffs and TAG wrapped cuff. |
| P040052/S007 10/1/08 |
MonoPrep PAP Test (MPPT) | Monogen, Inc. Lincolnshire, IL 60069 |
Change of vendor to PHARMCO-AAPER for the alcohol-based Specimen Transport Solution (MPPT-STS) that preserves specimen cellular morphology and inhibits microbial growth. |
| P040052/S008 10/16/08 |
MonoPrep PAP Test (MPPT) | Monogen, Inc. Lincolnshire, IL 60069 |
New supplier for the membrane component of the MPPT filter. |
| P050037/S011 10/16/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 5326 |
Installation of additional packaging equipment. |
| P050052/S012 10/16/08 |
Radiesse® Injectable Implant | Bioform Medical, Inc. Franksville, WI 5326 |
Installation of additional packaging equipment. |
| P060027/S006 10/17/08 |
Ovatio CRT | ELA Medical, Inc. Plymouth, MN 55441 |
Change the welding energy measurement method from an indirect method to a direct energy measurement method. |
| P060031/S001 10/9/08 |
Bio-Rad MONOLISA™ Anti-HBc EIA |
Bio-Rad Laboratories Diagnostics Group Redmond, WA 98052 |
Addition of a new filling machine for use in the manufacturing of the Positive and Negative Control vials and the Calibrator vial in the kit. |
| P060034/S001 10/9/08 |
Bio-Rad MONOLISA™ Anti-HBc IgM EIA |
Bio-Rad Laboratories Diagnostics Group Redmond, WA 98052 |
Addition of a new filling machine for use in the manufacturing of the Positive and Negative Control vials and the Calibrator vial in the kit. |
| P070013/S005 10/31/08 |
Evolence® Collagen Filler | Johnson & Johnson Consumer and Personal Products Worldwide Skillman, NJ 08558 |
Increase production scale of purified collagen during the manufacturing of the device. |
| P070015/S006 10/10/08 |
XIENCE V™ Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification to the environmental monitoring (EM) action limits for viable air and surface testing. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 61
Summary of PMA Originals Under Review
Total Under Review: 70
Total Active: 32
Total On Hold: 38
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 513
Total Active: 332
Total On Hold: 181
Number Greater Than 180 Days:
Summary of All PMA Submissions Received
Originals: 2
Supplements: 121
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 61
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 150.8
FDA Time: 98.8 Days MFR Time: 52 Days
Updated January 27, 2009
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