-
Medical Devices
-
November 2008 PMA Approvals
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
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P080011 11/19/08 |
BIOFINITY® (comfilcon A) Soft Contact Lens for Extended Wear alternate trade names: Aquaclear™ (comfilcon A) Soft Contact Lens and SiH48 (comfilcon A) Soft Contact Lens |
CooperVision, Inc, Pleasanton, CA 94588 |
Approval for the BIOFINITY® (comfilcon A) soft contact lens. This device is indicated for use as follows: BIOFINITY® (comfilcon A) Sphere and Aspheric soft contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY® (comfilcon A) Toric soft contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. BIOFINITY® (comfilcon A) Multifocal soft contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters with add powers from +0.50 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. BIOFINITY® (comfilcon A) Contact Lenses may be prescribed for Extended Wear for up to 6 nights and 7 days of continuous wear. It is recommended that the contact lens wearer be first evaluated on a Daily Wear schedule prior to overnight wear. The lenses may be prescribed for either one week disposable wear or for frequent replacement with cleaning, disinfection and scheduled replacement. When prescribed for frequent replacement, the lenses must be cleaned and disinfected using a chemical disinfection system only. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N12159/S023 11/26/08 180-Day |
Surgicel® Absorbable Hemostat | Ethicon Women’s Health & Urology Somerville , NJ 08876 |
Approval for manufacturing sites located at: 1) Ethicon SARL, Neuchatel, Switzerland; 2) Ethicon SARL, Marin Switzerland (warehouse); and 3) Studer AF/Werk Hard, Daniken, Switzerland (contract sterilizer). |
| N16895/S090 11/3/08 Real-Time |
Bausch & Lomb® SofLens® (polymacon) Contact Lens | Bausch & Lomb, Inc. Rochester , NY 14609 |
Approval for using a new supplier of polypropylene resin for the contact lens blister packs. |
| P810002/S065 11/5/08 180-Day |
St. Jude Medical Mechanical Heart Valves | St. Jude Medical St. Paul , MN 55117 |
Approval for a manufacturing site located in St. Paul, Minnesota. |
| P810002/S068 11/14/08 Real-Time |
SJM Regent Mechanical Heart Valve | St. Jude Medical St. Paul , MN 55117 |
Approval for modifications and rearrangement of the Instructions for Use (IFU). |
| P820003/S084 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 |
Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P840001/S098 11/5/08 Real-Time |
N’Vision Programming System | Medtronic Neurological Minneapolis , MN 55432 |
Approval for software updates made to N’Vision Programming System model 8840. |
| P850051/S068 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 |
Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P860004/S089 11/5/08 180-Day |
Medtronic SynchroMed II | Medtronic Neurological Minneapolis , MN 55432 |
Approval for the Medtronic Model 8835 Personal Therapy Manager (myPTM) and the Model 37092 Detachable antenna. |
| P860004/S090 11/10/08 180-Day |
Medtronic SynchroMed Pump and Infusion System (SynchroMed EL and SynchroMed II) | Medtronic Neurological Minneapolis , MN 55432 | Approval for the software changes made to the SynchroMed EL and SynchroMed II application software located on Model 8870 Application card. |
| P860019/S208 11/7/08 180-Day |
Apex™ Monorail™ and Over-the-Wire PTCA Dilatation Catheters | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for the Apex™ Monorail™ and Over-the-Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. The device, as modified, is indicated for: 1) (balloon models 1.5 – 5.0 mm) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) (balloon models 2.0 – 5.0 mm) for the post-delivery expansion of balloon expandable stents. |
| P880047/S012 11/26/08 180-Day |
Interceed® Absorbable Adhesion Barrier | Ethicon Women’s Health & Urology Somerville , NJ 08876 |
Approval for manufacturing sites located at: 1) Ethicon SARL, Neuchatel, Switzerland; 2) Ethicon SARL, Marin Switzerland (warehouse); and 3) Studer AF/Werk Hard, Daniken, Switzerland (contract sterilizer). |
| P890003/S145 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P900056/S086 11/5/08 Real-Time |
Rotablator™ Rotational Angioplasty System | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for the inclusion of additional electromagnetic compatibility (EMC) information in the Rotablator Console Directions for Use. |
| P900061/S077 11/21/08 180-Day |
Various Families of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P910023/S183 11/26/08 135-Day |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for a change to eliminate a chemical cleaning process for titanium case halves. |
| P910023/S190 11/14/08 Real-Time |
HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds. |
| P910023/S191 11/14/08 Real-Time |
Cadence ICD System Merlin@home Model EX1100 Transmitter | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the Merlin@home Model EX1100 Transmitter with inductive telemetry. |
| P910023/S194 11/26/08 Real-Time |
Current ICD | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices. |
| P910073/S075 11/7/08 Real-Time |
Endotak Reliance Family Active Fixation Tachy Leads | Boston Scientific CRM St. Paul , MN 55112 |
Approval for a lumen seal modification on Endotak Reliance, Reliance S, Reliance G, and Reliance SG lead families. |
| P910077/S090 11/17/08 180-Day |
Latitude™ Communicator Software & System Software | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs. |
| P920015/S045 11/14/08 135-Day |
Sprint Quattro Secure Lead Model 6935 | Medtronic, Inc. Mounds View, MN 55112 | Approval for a change in the treatment process for the lead silicone tubing. |
| P930022/S007 11/21/08 180-Day |
Legend Plus IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P950037/S059 11/4/08 180-Day |
Actros, Axios, BA03, Cylos, Dromos, Kairos, Philos, Philos II, and Protos Families of Pulse Generators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features |
| P950037/S064 11/24/08 Real-Time |
Cylos DR-T Pulse Generator | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for modifications to the header assembly and a correction to the technical manual. |
| P950037/S065 11/6/08 Real-Time |
Philos II Family of Pulse Generators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for modifications to the integrated circuits, header and can of the Philos II Family of Pulse Generators. |
| P950037/S066 11/21/08 Real-Time |
Philos II and Cylos Families of Pulse Generators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators. |
| P960009/S041 11/5/08 Real-Time |
N’Vision Programming System | Medtronic Neurological Minneapolis , MN 55432 | Approval for software updates made to N’Vision Programming System model 8840. |
| P960022/S005 11/3/08 Real-Time |
Bausch & Lomb® SofLens® 66 and SofLens® Toric (alphafilcon A) Contact Lens | Bausch & Lomb, Inc. Rochester , NY 14609 |
Approval for using a new supplier of polypropylene resin for the contact lens blister packs. |
| P960040/S174 11/17/08 180-Day | Teligen Family of ICD’s | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs. |
| P960040/S178 11/14/08 Real-Time |
Vitality Family of ICD's | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for changes to the Vitality HE programmer software Model 2896 Version 2.01, affecting the Vitality HE family of ICDs. |
| P970003/S102 11/12/08 Special |
NeuroCybernetic Prosthesis (NCP®) Programming Wand, Model 201 | Cyberonics, Inc. Houston , TX 77058 |
Approval for labeling changes that include the addition of confirmatory testing information, strengthening of warnings, and formatting revisions. |
| P970012/S038 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P970018/S014 11/7/08 Real-Time |
PrepStain™ System | BD Diagnostics Durham , NC 27703 |
Approval for a design change to improve shielding of the horizontal interface board and accompanying labeling changes to clarify precautions and instructions. |
| P980006/S013 11/3/08 Real-Time |
Bausch & Lomb® Purevision® (balafilcon A) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. Rochester , NY 14609 |
Approval for using a new supplier of polypropylene resin for the contact lens blister packs. |
| P980016/S145 11/21/08 180-Day |
Various Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P980022/S034 11/24/08 180-Day |
CareLink™ Pro (Model Number MMT-7335) | Medtronic MiniMed, Inc. Northridge , CA 91325 |
Approval for an update of software used in the CareLink™ pro, model MMT-7335 to version 1.2A. |
| P980023/S031 11/4/08 180-Day |
Cardiac Airbag and Belos Families of ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features |
| P980023/S035 11/21/08 Real-Time | Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators. |
| P980035/S095 11/5/08 135-Day |
Adapta/Sensia/ Versa Family of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds, View, MN 55112 | Approval for a new weld system. |
| P980035/S097 11/26/08 180-Day |
Medtronic Relia Implantable Pulse Generators | Medtronic, Inc. Mounds, View, MN 55112 | Approval for the Medtronic Relia™ series of pulse generators which are rate responsive, multi-programmable, single and dual chamber devices (Models REDR01, RED01, REVDD01, RESR01, RES01) and the associated SW010 applications software (Version 1.0). |
| P980035/S102 11/19/08 135-Day |
Adapta, Versa and Sensia Pacemakers | Medtronic, Inc. Mounds, View, MN 55112 | Approval for a reduction in the hybrid burn-in stress time for the Adapta, Versa, and Sensia pacemakers. |
| P980035/S107 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P980035/S119 11/25/08 Real-Time | Adapta, Versa and Sensia Family of Pacemakers | Medtronic, Inc. Minneapolis , MN 55112 | Approval for a minor design change for the L174 Hall sensor component used in the Medtronic Adapta, Versa and Sensia family of pacemakers. |
| P980049/S036 11/6/08 135-Day |
ICDs Ovatio VR 6250 and DR 6550
|
ELA Medical, Inc. Plymouth , MN 55441 | Approval for laser welding energy beam measurement intervals. |
| P980050/S035 11/21/08 180-Day |
Various Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P990001/S039 11/21/08 180-Day |
Various Families of Implantable Pulse Generators (IPGs) | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P990012/S005 11/13/08 180-Day |
Elecsys HBsAg Test System | Roche Diagnostics Indianapolis , IN 46250 | Approval for the extension of the Elecsys HBsAg Test System and the Elecsys Anti-HBs Test System onto the updated model of the Elecsys 2010 analyzer, known as the cobas e 411 analyzer. |
| P990025/S016 11/7/08 Special |
Navistar® RMT Catheter Family | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly. |
| P990056/S007 11/18/08 180-Day |
Elecsys® Total PSA Test System on cobas® e 411 Immunoassay Analyzer |
Roche Diagnostics Indianapolis , IN 46250 |
Approval for extension of the Elecsys® total PSA and CalSet II onto the updated model of the Elecsys 2010 analyzer, cobas® e 411 analyzer. |
| P000008/S013 11/25/08 135-Day |
LAP-BAND® Adjustable Gastric Banding (LAGB®) System | Allergan, Inc. Santa Barbara , CA 93111 | Approval for the implementation of a skip-lot testing option for the Force to Close test. |
| P000009/S026 11/4/08 180-Day |
Lumox, Xelos, and Lexos Families of ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features |
| P000009/S031 11/21/08 Real-Time |
Lexos and Lumos Families of Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators. |
| P000018/S043 11/19/08 180-Day |
Beta Cath System | Best Vascular Norcross , GA 30093 |
Approval of the post-approval study protocol. |
| P000054/S018 11/24/08 135-Day |
Infuse® Bone Graft | Medtronic, Inc. Memphis , TN 381132 | Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method. |
| P000058/S029 11/24/08 135-Day |
Infuse® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic, Inc. Memphis , TN 381132 | Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method. |
| P010012/S189 11/17/08 180-Day |
Cognis Family of CRT-D’s | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for the Next Generation (G2) RF communicator, Model 6476, which in conjunction with the Latitude System Software, v5.0, Model 6488, will add Latitude support for Cognis Teligen PGs. |
| P010014/S022 11/21/08 Special |
Oxford® Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw , IN 46581 |
Approval for the addition of a check of thickness prior to engraving of the meniscal bearing components of the Biomet Oxford Meniscal Unicompartmental Knew System to prevent components from being mis-engraved. |
| P010015/S048 11/21/08 180-Day | InSync Family of Cardiac Resynchronization Therapy (CRT) Pacemakers | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P010030/S012 11/14/08 Real-Time |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh , PA 15238 | Approval for two new Lithium ion cells that are used to construct the WCD 3000 battery pack. |
| P010031/S114 11/21/08 180-Day |
Various Families of CRT-Defibrillators | Medtronic, Inc. Mounds View, MN 55112 | Approval for component, design, manufacturing process, and labeling updates to the Medtronic 2090 CareLink Programmer, which are driven by component obsolescence. Updates include a new Touch Screen, a new Liquid Crystal Display (LCD), a Local Area Network (LAN) on the micro-Processing Unit (MPU), new Hard Drives, updates to the Link Electronics Module (LEM), and other minor changes to address obsolete components. |
| P010054/S007 11/13/08 180-Day |
Elecsys Anti-HBs Test System | Roche Diagnostics Indianapolis , IN 46250 | Approval for the extension of the Elecsys HBsAg Test System and the Elecsys Anti-HBs Test System onto the updated model of the Elecsys 2010 analyzer, known as the cobas e 411 analyzer. |
| P010068/S013 11/7/08 Special |
Navistar® RMT Catheter Family | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly. |
| P020004/S035 11/5/08 180-Day |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 | Approval for the distribution of the 2008 Annual Clinical Update to Physician Users for the Gore Excluder AAA Endoprosthesis. |
| P020014/S021 11/7/08 Real-Time |
Conceptus Essure™ System for Permanent Birth Control | Conceptus, Inc. Mountain View , CA 94041 | Approval for minor design changes to the Essure System, i.e., dimensional specification of the Delivery Wire Holder; change to the Release Band positioning; and a change to the Heat Shrink Tubing length. |
| P020018/S029 11/17/08 135-Day |
Zenith Flex® AAA Endovascular Graft and Renu™ AAA Ancillary Graft | Cook Medical, Inc. Bloomington , IN 47402 | Approval for an alternate vendor for polyester suture. |
| P020026/S052 11/14/08 135-Day |
Cordis CYPHER® Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 | Approval for reduction in a final acceptance activity test. |
| P020045/S025 11/14/08 Special |
Freezor Cardiac CryoAblation Catheters – Freezor Xtra and Freezor MAX Surgical CryoAblation Catheters and CCT.2 CryoConsole System | Cryocath Technologies., Inc. Kirkland , Canada H9H 5H3 | Approval for changing the manufacturing process of electrical cable subassembly. |
| P020056/S008 11/4/08 180-Day |
Allergan, Inamed Silicone Filled Breast Implant (Large PAS) | Allergan Goleta , CA 93117 |
Approval of the post-approval study protocol. |
| P030009/S025 11/4/08 135-Day |
Driver and Micro-Driver Coronary stent System | Medtronic Vascular Santa Rosa , CA 95403 | Approval for the automation of the stent segment loading process. |
| P030017/S029 11/18/08 180-Day |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Sylmar , CA 91342 |
Approval for a manufacturing site located at Boston Scientific Neuromodulation, Valencia, California. |
| P030025/S051 11/18/08 180-Day |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a manufacturing site located at Boston Scientific Corporation, Plymouth, Minnesota to manufacture the polymer excipient used in the device. |
| P030031/S012 11/7/08 Special |
Navistar® RMT Catheter Family | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly. |
| P030054/S098 11/26/08 135-Day |
Epic HF/Atlas + HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for a change to eliminate a chemical cleaning process for titanium case halves. |
| P030054/S106 11/14/08 Real-Time |
HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the HV Ceramic RF Module for the Current RF ICDs and Promote RF CRT-Ds. |
| P030054/S107 11/14/08 Real-Time |
Cadence ICD System Merlin@home Model EX1100 Transmitter | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the Merlin@home Model EX1100 Transmitter with inductive telemetry. |
| P030054/S109 11/26/08 Real-Time |
Promote CRT-D | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for minor changes to the Xena controller integrated circuit chip in the Current and Promote ICD/CRT-D devices. |
| P040002/S019 11/4/08 180-Day |
Powerlink 34mm Infrarenal Proximal Cuff Accessory | Endologix, Inc. Irvine , CA 92618 |
Approval for the 34mm infrarenal proximal cuff accessory for the Powerlink system. |
| P040016/S005 11/18/08 180-Day |
Liberté Monorail and Over-the-Wire Coronary Stent Systems | Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for a manufacturing site located at Boston Scientific Ireland, Ltd. (BSIL), Galway, Ireland. |
| P040033/S006 11/13/08 180-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew Orthopaedics Alexandria , VA 22314 | Approval for a line extension to the BHR System (ie., modular version of the BHR cup for uses with optional screws and apex/screw hold covers) and a site change (Smith & Nephew, Inc., Memphis, Tennessee). |
| P040036/S009 11/7/08 Special |
Navistar® RMT Catheter Family | Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for two additional Quality Control inspection steps: 1) adding a 100% visual inspection of the PCB boards to verify that all components are present, and 2) adding an EEPROM read step during the existing calibration process to verify that all PCB components are present and functioning properly. |
| P040038/S013 11/10/08 135-Day |
Xact® Carotid Stent System | Abbott Vascular, Inc. Santa Clara , CA 95054 |
Approval to move the Xact® manufacturing processes within the existing manufacturing facility and to move two pieces of duplicate manufacturing equipment from one building to another. |
| P040043/S024 11/7/08 Real-Time |
Gore TAG Thoracic Endoprosthesis Delivery System | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 | Approval for modifications to the distal end of the delivery system where the endograft is constrained and changes to the delivery catheter hub, and is indicated for endovascular repair of aneurysms of the descending thoracic aorta in patients who have appropriate anatomy. |
| P050016/S004 11/4/08 180-Day |
Cormet Hip Resurfacing System | Corin USA Tampa , FL 33612 |
Approval of the post-approval study protocol. |
| P050023/S011 11/4/08 180-Day |
Lumax Family of ICD/CRT-Ds | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features |
| P050023/S018 11/21/08 Real-Time |
Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators. |
| P050028/S001 11/12/08 Real-Time |
COBAS TaqMan HBV Test for use with the High Pure System | Roche Molecular Systems, Inc. Pleasanton , CA 94588 | Approval for the shelf life extension of the TaqMan HBV Test components/kits in the COBAS TaqMan HBV Test for use with the High Pure System. |
| P050039/S001 11/13/08 180-Day |
Novation™ Ceramic AHS™ | Exactech, Inc. Gainsville , FL 32653 |
Approval for an additional machining processes at Exactech, Inc. in Gainesville, Florida. |
| P050039/S002 11/19/08 135-Day |
Exactech® Novation® Ceramic AHS® Articulation Hip System | Exactech Gainesville , FL 32653 |
Approval for the addition of a new raw material supplier. |
| P050051/S003 11/13/08 Real-Time |
Architect® AUSAB® Reagent Kit, Architect® AUSAB® Calibrators and Architect® AUSAB® Controls | Abbott Laboratories Abbott Park , IL 60064 | Approval for change of grayzone range and changes to the output of the assay file interpretation screen. |
| P050053/S009 11/24/08 135-Day |
Infuse® Bone Graft | Medtronic, Inc. Memphis , TN 381132 | Approval for additional treatment processing vessels, upgrades to process equipment and automation of a test method. |
| P060033/S010 11/4/08 135-Day |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 | Approval for the automation of the stent segment loading process. |
| P060037/S004 11/6/08 180-Day |
Legacy Knee-Posterior Stabilized (LPS), Flex Mobile Bearing Knee | Zimmer, Inc. Warsaw , IN 46581 | Approval of the post-approval study protocol. |
| P070008/S001 11/4/08 180-Day |
Stratos LV/LV-T Family of CRT-Ps | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the addition of models 500/540 to the Lumax family of ICD/CRT-Ds and ICS 3000 Programmer. These models would contain: • A third programmable cardioversion / defibrillation shock pathway to offer more programming options • Automatic Threshold Measurement (ATM) feature • Electronic module (hardware) updates to support the third programmable shock path • Modifications to the Litronik batteries to increase capacity • New standard value of the programmable pacing pulse width • Updated RAM firmware to support new features |
| P070008/S005 11/6/08 180-Day |
Stratos LV CRT-P & Stratos LV-CRT-P OTW Lead & COROX OTW BP Lead | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval of the post-approval study protocol. |
| P070008/S007 11/21/08 Real-Time |
Stratos LV-T Pulse Generator | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for updates to the Home Monitoring Service Center used with the Philos II and Cylos Families of Pulse Generators Lexos and Lumos Families of Implantable Cardioverter Defibrillators. Stratos LV-T Pulse Generator. Cardiac Airbag-T and Belos VR-T Implantable Cardioverter Defibrillators, and the Kronos LV-T and Lumax Families of Implantable Cardioverter Defibrillators. |
| P070016/S001 11/26/08 180-Day |
Zenith® TX2® Thoracic Endovascular Graft | Cook, Inc. Bloomington , IN 47404 | Approval of the post-approval study protocol. |
| P070016/S002 11/25/08 180-Day |
Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47404 | Approval for use of a modified introduction system, the Z-Trak™ Plus Introduction System, with the Zenith TX2® TAA Endovascular Graft. |
| P070027/S002 11/5/08 180-Day |
Talent Abdominal Stent Graft System | Medtronic, Inc. Santa Rosa , CA 95403 | Approval of the post-approval study protocol. |
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 |
|---|---|---|---|
| P780007/S044 11/21/08 | Biomedics 38 (Polymacon) Hydrophilic Contact Lenses | CooperVision, Inc. Norfolk , VA 23507 |
Migration to an in-blister hydration process for the Polymacon 38 lenses. |
| P840001/S121 11/6/08 | RestoreULTRA Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis , MN 55432 | Addition of a dual pin press to the manufacturing process. |
| P840064/S037 11/26/08 | VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices |
Alcon Research, Ltd. Fort Worth , TX 76134 |
Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process. |
| P860019/S229 11/4/08 | PTCA Catheters | Boston Scientific Corporation Maple Grove , MN 55311 |
Alternate method for final packaging of the device including label design changes under the BSC master brand. |
| P880086/S169 11/13/08 | Affinity, Integrity, Identity, Victory, and Zephyr Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps |
| P890003/S152 11/14/08 | Model 2490C and 2490R CareLink® Monitors | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Changes to the test codes applied during the inline quality control test system used for the device. |
| P890047/S025 11/26/08 | VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth , TX 76134 |
Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process. |
| P910023/S192 11/21/08 | Cadence Family of ICDs | St. Jude Medical, Inc. Sylmar , CA 91342 |
Addition of an alternate vendor to package ICD plugs. |
| P920015/S049 11/26/08 | Sprint Quattro Secure Lead Models 6935 and 6947 | Medtronic, Inc. Mounds View, MN 55112 | Modification to the sleeve head bonding process and to the Adhesive Dab Application to the Overlay Tubing Slit process. |
| P940040/S010 11/25/08 | Roche Molecular Systems AMPLICOR Mycobacterium Tuberculosis (MTB) Test | Roche Molecular Systems, Inc. Pleasanton , CA 94588 | Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the AMPLICOR Mycobacterium Tuberculosis (MTB) Test with the activator 4,5 Dicyanoimidazole (DCI). |
| P960030/S024 11/26/08 | IsoFlex Optim Family of Leads | St. Jude Medical CRMD Sylmar , CA 91342 |
Elimination of the plasma priming process. |
| P960040/S179 11/21/08 | Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens. |
| P970004/S063 11/25/08 | InterStim II® Model 3058 Neurostimulator | Medtronic, Inc. Minneapolis , MN 55432 | Change in the final clean and inspection process for the device. |
| P970008/S040 11/19/08 | Urologix Targix® System | Urologix, Inc. Minneapolis , MN 55447 | Change of an adhesive and the test method for measuring tensile strength. |
| P980016/S160 11/5/08 | Maximo, Marquis, Intrinsic 30/ Intrinsic, EnTrust, and Virtuoso ICDs | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Addition of an in-process leakage test. |
| P980016/S161 11/7/08 | Maximo DR/VR, Marquis DR/VR, and Intrinsic ICDs | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Addition of a cleaning step. |
| P980016/S162 11/13/08 | Virtuoso ICD | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Alternate vendor of raw material used in flex circuit manufacture. |
| P980022/S038 11/14/08 | Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic Diabetes Northridge , CA 91325 | Changes to the rinse and dry times, addition of a new adhesive for the occlusion sensor, and change to the sensor encasement. |
| P980022/S039 11/20/08 | Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic Diabetes Northridge , CA 91325 | Changes to the sensor to tube assembly, sealing and beveling. |
| P980022/S040 11/24/08 | Paradigm Real-Time Insulin Pump | Medtronic MiniMed Northridge , CA 91325 | Change in a vendor supplying a component of the device. |
| P990023/S005 11/26/08 | VISCOAT®, DUOVISC®, DISCOVISC®, PROVISC® AND CELLUGEL® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth , TX 76134 |
Use of a new industrial disinfectant for the disinfection of cleanrooms used during the production process. |
| P010012/S193 11/21/08 | Vitality AVT, Confient, Confient AV, Vitality DS, Vitality EL, Vitality DS VR, Vitality 2 DR, Vitality 2 DR EL, Vitality 2 VR, Vitality 2 VR EL, Vitality HE | Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Changes in the soak process time for high voltage capacitors and the addition of digital timers to the primary soak ovens. |
| P010031/S128 11/5/08 | Concerto, InSync Sentry, InSync Sentry, InSync II Marquis, InSync III Marquis, InSync II Protect, and InSync Maximo CRT-Ds | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Addition of an in-process leakage test. |
| P010031/S129 11/13/08 | Concerto CRT-D | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 | Alternate vendor of raw material used in flex circuit manufacture. |
| P020004/S038 11/26/08 | Gore Excluder® AAA Endoprosthesis (Excluder Device) | W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 | Change in the method used for cooling the endoprosthesis prior to crushing and subsequent loading onto the delivery device. |
| P020009/S047 11/4/08 | Express 2 MR & OTW Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Alternate method for final packaging of the device including label design changes under the BSC master brand. |
| P030009/S027 11/13/08 | Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Modification of the manufacturing equipment to allow increased capacity. |
| P030035/S048 11/13/08 | Frontier and Frontier II Family of CRT-Ps | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Addition of an alternate vendor for the parylene dimer used to parylene coat pacemakers and CRT-Ps |
| P040047/S009 11/14/08 | Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
Addition of a new supplier for a component used in the packaging of the device. |
| P050028/S002 11/25/08 | Roche Molecular Systems COBAS TaqMan HBV Test for use with the High Pure System | Roche Molecular Systems, Inc. Pleasanton , CA 94588 | Replacement of Tetrazole, an activator used in the automated DNA synthesis of RMS oligonucleotides use in the COBAS TaqMan HBV Test for use with the High Pure System with the activator 4,5 Dicyanoimidazole (DCI). |
| P050037/S012 11/6/08 | Radiesse Injectable Gel | BioForm Medical, Inc. Franksville , WI 53126 |
Qualification of a modified pyrogen test method. |
| P050037/S013 11/14/08 | Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
New supplier for a packaging component for the device. |
| P050037/S014 11/21/08 | Radiesse ® Injectable Gel | BioForm Medical, Inc. Franksville , WI 53126 |
Alternate vendor for glycerin, a component used in the device. |
| P050044/S006 11/14/08 | Vitagel™ Surgical Hemostat | Orthovita, Inc. Malvern , PA 19355 |
Installation of a second manufacturing line. |
| P050044/S007 11/21/08 | Vitagel™ Surgical Hemostat | Orthovita, Inc. Malvern , PA 19355 |
Change of vendor and change of manufacturing parameters. |
| P050052/S013 11/6/08 | Radiesse Injectable Gel | BioForm Medical, Inc. Franksville , WI 53126 |
Qualification of a modified pyrogen test method. |
| P050052/S014 11/14/08 | Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville , WI 53126 |
New supplier for a packaging component for the device. |
| P050052/S015 11/21/08 | Radiesse ® Injectable Gel | BioForm Medical, Inc. Franksville , WI 53126 |
Alternate vendor for glycerin, a component used in the device. |
| P060008/S001 11/21/08 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System (Over-the-Wire) | Boston Scientific Corporation Maple Grove , MN 55311 |
Change in supplier of a device component. |
| P060008/S002 11/20/08 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change to an in-process test method and corresponding specifications. |
| P060008/S003 11/20/08 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Implementation of an in-process automated manufacturing improvement. |
| P060008/S005 11/26/08 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Change in the method used to create the proximal marks on the shaft of the Over-the-Wire catheter. |
| P060008/S006 11/26/08 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove , MN 55311 |
Implementation of an in-process automated manufacturing improvement. |
| P060022/S001 11/19/08 | Akreos® Posterior Chamber Intraocular Lens | Bausch & Lomb, Inc., Rochester , NY 14609 |
Change in site for the bioburden and endotoxin testing. |
| P060025/S001 11/26/08 | ATS 3f® Aortic Bioprosthesis | ATS Medical, Inc. Lake Forest , CA 92630 | Change in supplier for the Tab Cloth fabric. |
|
P060033/S015 11/13/08
|
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 | Change in vendor for molded components used in the manufacture of the device. |
|
P060033/S016 11/13/08
|
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 | Equipment modification to increase the capacity at an in-process work step. |
|
P060033/S017 11/19/08
|
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 | Changes to the Endeavor Sprint Zotarolimus-Eluting Coronary Stent System: 1) reuse of catheter hoops; 2) eliminate pre-PC spray inspection work step; 3) welding process automation; 4) alternative pouch sealing equipment; 5) change to stent storage and transportation vial; and 6) conical spray jar assembly. |
|
P060033/S018 11/20/08
|
Endeavor Zotarolimus-Eluting and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa , CA 95403 | Change to the packaging and loading configurations used in the sterilization process. |
| P060033/S019 11/13/08 | Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Modification of the manufacturing equipment to allow increased capacity. |
| P060033/S024 11/26/08 | Endeavor Zotarolimus-Eluting Coronary Stent System and Endeavor Sprint Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Changes to the in-process monitoring at the PC Overspray workstep. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 98
Summary of PMA Originals Under Review
Total Under Review: 67
Total Active: 27
Total On Hold: 40
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 535
Total Active: 348
Total On Hold: 187
Number Greater Than 180 Days: 18
Summary of All PMA Submissions Received
Originals: 1
Supplements: 183
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 98
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 177
FDA Time: 95.4 Days MFR Time: 81.6 Days
-
-