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.
None.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810002/S067 8/29/08 Real-Time |
SJM Masters Series Aortic Valved Graft (model CAVGJ), and the SJM Master HP Valved Graft (model VAVGJ) | St. Jude Medical St. Paul, MN 55117 |
Approval for a modification to the packaging for the referenced models. |
| P810031/S035 8/1/08 180-Day |
Healon, Healon GV, and Healon5 Sodium Hyaluronate Ophthalmic Viscoelastic Devices | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for a new contract sterilizer for secondary packaging. |
| P810046/S226 8/21/08 180-Day |
VOYAGER™ NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for the VOYAGER™ NC Coronary Dilatation Catheter. The device, as modified, will be marketed under the trade name VOYAGER™ NC Coronary Dilatation Catheter and is indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis of the purpose of improving myocardial perfusion; 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction; 3) balloon dilatation of a stent after implantation. |
| P840001/S107 8/18/08 135-Day |
Synergy and Prime Families of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P860003/S049 8/29/08 Real-Time |
Therakos UVAR® XTS Photopheresis System | Therakos Exton, PA 19341 |
Approval for a material change for the gasket used in the centrifuge bowl cover of the UVAR® XTS Photopheresis System. |
| P860004/S097 8/18/08 135-Day |
SynchroMed II Implantable Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P860057/S029 8/29/08 180-Day |
Carpentier-Edwards® Perimount MAGNA™ Mitral Pericardial Bioprostheses, Models 7000 and 7000TFX | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for design and manufacturing modifications to the Carpentier-Edwards® Perimount Plus® Mitral Pericardial Bioprostheses, Models 6900P and 6900PTFX including changes to the Elgiloy® band, the polyester band, and the silicone waffle sewing ring/cuff. The device, as modified, will be marketed under the trade name Carpentier-Edwards® Perimount MAGNA™ Mitral Pericardial Bioprostheses, Models 7000 and 7000TFX and is indicated for the replacement of malfunctioning native or prosthetic mitral valves. |
| P880031/S014 8/22/08 180-Day |
Healon D™ | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval to move the manufacture of Vitrax from the Allergan facility in Westport, Ireland to the AMO Uppsala facility in Sweden, for a 0.4 mL fill volume in addition to the currently approved 0.65 mL fill volume, and re-brand the dispersive Vitrax product manufactured in Uppsala, Sweden as Healon D™ (dispersive). |
| P910023/S185 8/19/08 Special |
Cadence ICD System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for modifications to the QuickStart Guide (labeling for the Merlin@home DM EX1150 transmitter.) |
| P910061/S014 8/28/08 Real-Time |
Soflex™ Posterior Chamber Intraocular Lens (Models: LI61AOV, LI61AO, LI61SE and LI61U) | Bausch & Lomb San Dimas, CA 91773 |
Approval for use of the Easy Load Lens Retainer for packaging the LI61AO lens. |
| P910071/S012 8/22/08 180-Day |
ADATO SIL-OL 5000 Silicone Oil | Bausch and Lomb, Inc. Rochester, NY 14609 |
Approval for a manufacturing site located at Pharmpur GmbH, Königsbrunn, Germany. |
| P940040/S009 8/26/08 180-Day |
AMPLICOR Mycobacterium Tuberculosis Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Somerville, New Jersey for bulk manufacturing and filling operations. |
| P960009/S047 8/18/08 135-Day |
Kinetra Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P970004/S050 8/18/08 135-Day |
Interstim II Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P970038/S012 8/13/08 180-Day |
Access® Hybritech® Free PSA | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the addition of a calibration traceable to the World Health Organization 1 st International Reference Preparation 96/668 for the Access Hybritech Free PSA assay |
| P980016/S121 8/18/08 135-Day |
Virtuoso ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the laser ribbon bonding process. |
| P980016/S135 8/28/08 Real-Time |
Virtuoso DR/VR, Entrust DR/VR, Maximo DR/VR Families of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the RV Lead Integrity Alert (RVLIA) feature and Model SW012, Version 1.0, RVLIA Software. |
| P980035/S088 8/4/08 135-Day |
EnRhythm IPG Model P150DR and AT500 IPG Model AT501 | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P000006/S010 8/22/08 180-Day |
Titan Inflatable Penile Prosthesis | Coloplast A/S Minneapolis, MN 55411 |
Approval for revision to the labeling to include the results of the 5-year postapproval study. |
| P000008/S012 8/26/08 180-Day |
LAP-BAND® Adjustable Gastric Banding (LAGB®) System | Allergan, Inc. Goleta, CA 93117 |
Approval for design changes to the RapidPort™ System. The device, as modified, will be marketed under the trade name RapidPort™ EX. |
| P000010/S012 8/26/08 180-Day |
AMPLICOR HCV Test, version 2.0 | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Somerville, New Jersey for bulk manufacturing and filling operations. |
| P000012/S016 8/26/08 180-Day |
COBAS AMPLICOR HCV Test, version 2.0 | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Somerville, New Jersey for bulk manufacturing and filling operations. |
| P000012/S017 8/26/08 180-Day |
COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, version 2.0 | Roche Molecular System, Inc. Pleasanton, CA 94588 |
Approval for a manufacturing site located at Roche Molecular Systems, Inc., Somerville, New Jersey for bulk manufacturing and filling operations. |
| P000025/S036 8/27/08 180-Day |
COMBI 40+ Cochlear Implant System | Med-El Corporation Durham, NC 27713 |
Approval for a manufacturing site located in Innsbruck, Austria. |
| P000054/S015 8/15/08 180-Day |
INFUSE® Bone Graft | Medtronic, Inc. Memphis, TN 38132 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico, and a sterilizing site at Steritech, Inc., Salinas, Puerto Rico. |
| P000058/S026 8/15/08 180-Day |
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic, Inc. Memphis, TN 38132 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico, and a sterilizing site at Steritech, Inc., Salinas, Puerto Rico. |
| P010012/S188 8/28/08 Real-Time |
Contak Renewal 3 RF and Livian Families of CRT-D Models H210, H215, H220, and H225 | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Approval for the addition of polyimide tape to the weld ring. |
| P010014/S021 8/15/08 Real-Time |
Oxford® Partial Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval for the addition of Computer Aided Surgery (CAS) navigation surgical instruments for use with the BrainLAB uni-knee Image Guidance System for use with the Oxford® Partial Knee System. The device, as modified, will be marketed under the trade name Oxford® Partial Knee System and is intended for use in individuals with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and is intended to be implanted with bone cement. |
| P010015/S039 8/4/08 135-Day |
InSync III CRT-P Model 8042 | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the workstations used for welding battery header subassemblies. |
| P010031/S091 8/18/08 135-Day |
Concerto ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for changing the laser ribbon bonding process. |
| P010031/S104 8/28/08 Real-Time |
Concerto/ InSync Sentry/ InSync Maximo Families of CRT-Ds |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for the RV Lead Integrity Alert (RVLIA) feature and Model SW012, Version 1.0, RVLIA Software. |
| P020012/S003 8/13/08 180-Day |
Artefill Collagen Dermal Implant | Artes Medical, Inc. San Diego, CA 92121 |
Approval of the post-approval study. |
| P020036/S010 8/7/08 Special |
SMART™ Control Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Approval to incorporate a functional torque specification for the slider assembly of the SMART Control Nitinol Stent Delivery System. |
| P020056/S006 8/6/08 180-Day |
Natrelle Silicone-Filled Breast Implants | Allergan Goleta, CA 93117 |
Approval of the post-approval study. |
| P030006/S019 8/13/08 Real-Time |
Prolieve Thermodilitation System | Boston scientific Corporation Urology/ Gynecology Marlborough, MA 01752 |
Approval for modification and replacement of the thermoelectric controller board. |
| P030011/S003 8/11/08 180-Day |
CardioWest™ Temporary Total Artificial Heart (TAH-t) System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval of the post-approval study. |
| P030017/S042 8/20/08 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for multiple changes to the assembly methods of the IPG Header. |
| P030017/S049 8/27/08 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for changes to the implantable pulse generator leakage test. |
| P030017/S052 8/27/08 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for a change to the RF Tip Assembly Process for Lead Assemblies. |
| P030017/S054 8/21/08 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for modifications to the assembly procedure for a surgical lead. |
| P030017/S057 8/19/08 135-Day |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for a packaging change. |
| P030039/S010 8/18/08 Real-Time |
CoSeal Surgical Sealant | Baxter Healthcare Corp. McGaw Park, IL 60085 |
Approval for modification to the 3 ml syringe for the PEG component of the 2 ml configuration of the device. |
| P030050/S003 8/13/08 180-Day |
Sculptra® (injectable poly-L-lactic acid) | Sanofi Aventis, U.S. LLC Bridgewater, NJ 08807 |
Approval of the post-approval study. |
| P030054/S100 8/19/08 Special |
Epic HF CRT-D System | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for modifications to the QuickStart Guide (labeling for the Merlin@home DM EX1150 transmitter). |
| P040013/S013 8/29/08 180-Day |
GEM 21S® | Luitpold Pharmaceuticals, Inc. Norristown, PA 19403 |
Approval for: 1) addition of a claim that PDGF stimulates angiogenesis; 2) addition of a comparison of pivotal clinical trial results obtained with GEM 21S® and the results published on Emdogain®; and 3) addition of 36 month long term efficacy data to the original 6 month study. |
| P040024/S018 8/6/08 135-Day |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Approval for a change in test method for hyaluronic acid and gel content used in the manufacturing of the device. |
| P040037/S007 8/14/08 Panel |
VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval of an extension of the indications for use to include iliac arterial lesions. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4.0-12.0 mm. |
| P040043/S023 8/20/08 180-Day |
GORE TAG® Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for the distribution of the 2008 Annual Clinical Update to Physician Users for the device. |
| P040052/S005 8/11/08 180-Day |
MonoPrep PAP Test (MPPT) | MonoGen, Inc. Lincolnshire, IL 60069 |
Approval for manufacturing sites located in Lincolnshire, Illinois and Waukegan, Illinois. |
| P050007/S009 8/25/08 180-Day |
StarClose™ and StarClose™ SE Vascular Closure Systems | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for modifications to the indications for use. The device, as modified, will be indicated for the following: The percutaneous closure of common femoral artery access sites while reducing times to hemostasis, ambulation, and dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. The StarClose Vascular Closure System is indicated for use to allow patients who have undergone diagnostic endovascular catheterization procedures to ambulate and be eligible for discharge as soon as possible after device placement. The StarClose Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. |
| P050053/S005 8/15/08 180-Day |
INFUSE® Bone Graft | Medtronic, Inc. Memphis, TN 38132 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico, and a sterilizing site at Steritech, Inc., Salinas, Puerto Rico. |
| P070001/S002 8/11/08 180-Day |
ProDisc™-C© Total Disc Replacement | Synthes Spine West Chester, PA 19380 |
Approval of the post-approval study. |
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 |
| P790005/S045 8/15/08 |
EBI OsteoGen™ Implantable Bone Growth Stimulator | Biomet, Inc. Parsippany, NJ 07054 |
Addition of a conformal coating adhesive to the electronic printed circuit boards of the device. |
| P850035/S032 8/15/08 |
EBI SpF™ Implantable Spinal Fusion Stimulator | Biomet, Inc. Parsippany, NJ 07054 |
Addition of a conformal coating adhesive to the electronic printed circuit boards of the device. |
| P880091/S027 8/8/08 |
STAAR Surgical Elastimide®, Elastic®, and Elastic® Toric UV Absorbing Posterior Chamber Intraocular Lenses (all models) | STAAR Surgical, Co. Monrovia, CA 91016 |
Change in packaging materials. |
| P920015/S047 8/8/08 |
Sprint Quattro Lead Model 6935 | Medtronic, Inc. Mounds View, MN 55112 |
Changes in the following areas: 1) a change in the chart recorder to monitor the sterilization process; 2) a change in ethylene oxide (EO) sterilization exposure time; and 3) a change in the inspection method of the coating on the inner diameter of the tubing component. |
| P930014/S026 8/27/08 |
AcrySof® Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Improved coating process for the AcrySert® Delivery System. |
| P930014/S027 8/28/08 |
AcrySof® Toric Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Changes to the bench quality control inspection software, the use of a semi-automated motorized rotary stage, and other lens bench equipment upgrades. |
| P960040/S172 8/14/08 |
TELIGEN HE | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the solder ball shear inspection test process. |
| P960040/S173 8/21/08 |
VITALITY HE and CONFIENT Families of Implantable Cardioverter Defibrillators (ICDs) | BSC/Guidant Cardiac Rhythm Management St. Paul, MN 55112 |
Change in a material supplier. |
| D970012/S055 8/8/08 |
AMS 700 Inflatable Penile Prosthesis (IPP) | American Medical Systems Minnetonka, MN 55343 |
Utilization of an additional fabrication system in the manufacturing process of the device. |
| P970021/S021 8/21/08 |
The Gynecare Thermachoice* III | Ethicon, Inc., Women’s Health and Urology Somerville, NJ 08876 |
Modification to a component assembly location. |
| P970021/S022 8/25/08 |
The Gynecare Thermachoice* III | Ethicon, Inc., Women’s Health and Urology Somerville, NJ 08876 |
Change to the curing system in the catheter assembly process. |
| P970031/S023 8/7/08 |
FREESTYLE® Aortic Root Bioprosthesis (Models 995, 995MS and 995CS) | Medtronic Heart Valves Santa Ana, CA 92705 |
Additional raw material supplier. |
| P970051/S046 8/29/08 |
Nucleus Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Change in the welding procedure for the CI24R and CI24RE devices. |
| P980016/S139 8/1/08 |
Secura DR/VR and Maximo II DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields. |
| P980016/S141 8/14/08 |
Virtuoso Dual Chamber ICD | Medtronic, Inc. Mounds View, MN 55112 |
Use of an alternate epoxy and modification to the Laser Ribbon Bonding Equipment. |
| P980016/S142 8/15/08 |
Secura and Maximo II DR/VRs | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Five modifications to the Final Functional Electrical Testing for the devices. |
| P980016/S143 8/22/08 |
Maximo, Marquis Intrinsic, Entrust, Virtuoso, Maximo II DR/VR, Secura DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Requested a new photo developer recipe. |
| P980022/S032 8/28/08 |
Medtronic MiniMed Continuous Glucose Monitoring System | Medtronic MiniMed Northridge, CA 91325 |
Changes to the glucose sensor’s coating process. |
| P980035/S104 8/14/08 |
EnRhythm Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Use of an alternate epoxy and modification to the Laser Ribbon Bonding Equipment. |
| P980035/S105 8/22/08 |
EnRhythm Implantable Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 |
Requested a new photo developer recipe. |
| P980037/S026 8/4/08 |
AngioJet® Rheolytic™ Thrombectomy System | Possis Medical, Inc. Minneapolis, MN 55433 |
Modification in the sterilization manufacturing procedure. |
| P980044/S008 8/29/08 |
Supartz™ | Smith & Nephew, Inc. Memphis, TN 38116 |
Updating of an in-process test instrument. |
| P990001/S038 8/14/08 |
C-Series and T-Series Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Use of an alternate epoxy and modification to the Laser Ribbon Bonding Equipment. |
| P990037/S026 8/7/08 |
Vascular Solutions Duett Sealing Device | Vascular Solutions, Inc. Minneapolis, MN 55369 |
Change in the quality control device used to monitor the sterilization process, and a change in the materials used in one accessory component (small bore applicator tip). |
| P990064/S025 8/7/08 |
MOSAIC® PORCINE Bioprosthesis (Models 305, 310) | Medtronic Heart Valves Santa Ana, CA 92705 |
Additional raw material supplier. |
| P000053/S017 8/8/08 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Utilization of an additional fabrication system in the manufacturing process of the device. |
| P010012/S186 8/14/08 |
COGNIS HE | BSC/Guidant Cardiac Rhythm Management St. Paul, MN 55112 |
Changes to the solder ball shear inspection test process. |
| P010012/S187 8/21/08 |
CONTAK RENEWAL and LIVIAN Families of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) | BSC/Guidant Cardiac Rhythm Management St. Paul, MN 55112 |
Updates to the manufacturing test software. |
| P010012/S190 8/29/08 |
EASYTRAK 3 IS-1/LV-1 Family of Heart Failure Leads |
BSC/Guidant Cardiac Rhythm Management St. Paul, MN 55112 |
Change in a material supplier. |
| P010019/S010 8/6/08 |
CIBA VISION® (lotrafilcon A and lotrafilcon B) Soft Contact Lenses | CIBA Vision Corporation Duluth, CA 30097 |
Change in the plasma treatment process, using an alternate gas mixture to maintain uninterrupted stream of product inventory. |
| P010020/S010 8/8/08 |
Acticon Neosphincter Artificial Bower Sphincter | American Medical Systems Minnetonka, MN 55343 |
Utilization of an additional fabrication system in the manufacturing process of the device. |
| P010031/S108 8/1/08 |
Consulta CRT-D and Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Change in the cleaning process for titanium shields. |
| P010031/S110 8/14/08 |
Concerto CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Use of an alternate epoxy and modification to the Laser Ribbon Bonding Equipment. |
| P010031/S111 8/15/08 |
Consulta and Maximo II CRT-Ds | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Five modifications to the Final Functional Electrical Testing for the devices. |
| P010031/S112 8/22/08 |
InSync Sentry, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Maximo, Concerto, Maximo II, Consulta Family of CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Requested a new photo developer recipe. |
| P020009/S045 8/1/08 |
Express™/ Express 2™ Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of a redundant in-process inspection step. |
| P020026/S053 8/4/08 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System (Cypher Stent) | Cordis Corporation Miami Lakes, FL 33014 |
Removal of a stent inspection test used in the manufacture of the Cypher Stent. |
| P020026/S055 8/20/08 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System (Cypher Stent) | Cordis Corporation Miami Lakes, FL 33014 |
Alternate testing location for a set of quantitative test methods. |
| P020026/S056 8/28/08 |
CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System (Cypher Stent) | Cordis Corporation Miami Lakes, FL 33014 |
Alternate in process quality inspection method for the device. |
| P030025/S057 8/1/08 |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of a redundant in-process inspection step. |
| P0300036/S008 8/29/08 |
SelectSecure Model 3830 Lead | Medtronic, Inc. Mounds View, MN 55112 |
Facility transfer of a component manufacturer. |
| P030047/S014 8/14/08 |
PRECISE® RX Nitinol Stent System and PRECISE® PRO Rx™ Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Addition of a set-up verification step in the support member assembly process. |
| P040002/S020 8/27/08 |
Powerlink® System with Visiflex Delivery Catheter System™ (Powerlink System) | Endologix, Inc. Irvine, CA 92618 |
Change in one of the parameters used in the graft processing procedure of the Powerlink System. |
| P040016/S032 8/1/08 |
Liberté™ Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of a redundant in-process inspection step. |
| P040024/S027 8/22/08 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corp. Scottsdale, AZ 85256 |
Change to eliminate the extrusion force test from the long term stability testing program for Restylane® Injectable Gel and Perlane® Injectable Gel. |
| P050010/S003 8/26/08 |
ProDisc™ - L Total Disc Replacement | Synthes Spine West Chester, PA 19380 |
Relocation of the laser etch marking. |
| P050020/S006 8/6/08 |
Freestyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Transfer an inspection step to Steven Label and also to semi-automate the inspection step. |
| P050020/S007 8/25/08 |
Freestyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Change to combine three separate manual processes into a semi-automated process and a vendor change from Asahi Polyslider to Oberg Industries. |
| P050046/S003 8/29/08 |
ACUITY Steerable Family of Heart Failure Leads | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Change in a material supplier. |
| P060033/S012 8/8/08 |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Equipment modification to increase the capacity at the pillow forming work step. |
| P060039/S001 8/8/08 |
Attain StarFix Lead Model 4195 | Medtronic, Inc. Mounds View, MN 55112 |
Changes in the following areas: 1) a change in the chart recorder to monitor the sterilization process; 2) a change in ethylene oxide (EO) sterilization exposure time; and 3) a change in the inspection method of the coating on the inner diameter of the tubing component. |
| P070013/S001 8/14/08 |
EVOLENCE® Collagen Dermal Filler | Johnson & Johnson Consumer and Personal Products Worldwide Skillman, NJ 08558 |
Increase in production capacity for the device. |
| P070015/S003 8/28/08 |
Xience V™ Everolimus Eluting Coronary stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Replacement of the exiting manual mandrel removal process with a semi-automated process. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 52
Summary of PMA Originals Under Review
Total Under Review: 76
Total Active: 30
Total On Hold: 46
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 511
Total Active: 360
Total On Hold: 151
Number Greater Than 180 Days: 17
Summary of All PMA Submissions Received
Originals: 4
Supplements: 143
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 188.6
FDA Time: 114.9 Days MFR Time: 73.7 Days
Updated September 22, 2008
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Center for Devices and Radiological Health / CDRH
