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 |
|---|---|---|---|
| P050028 9/4/08 |
COBAS® TaqMan® HBV Test for use with the High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for COBAS ® TaqMan ® HBV Test for use with the High Pure System. This device is indicated for: The COBAS ® TaqMan ® HBV Test For Use With The High Pure System is an in vitro nucleic acid amplification test for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA), using the High Pure Viral Nucleic Acid Kit for manual specimen preparation and the COBAS ® TaqMan ® 48 Analyzer for automated amplification and detection. The test is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the COBAS ® TaqMan ® HBV Test must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with adefovir dipivoxil. Assay performance for determining the state of HBV infection has not been established. The COBAS ® TaqMan ® HBV Test is not intended for use as a screening test for blood or blood products for the presence of HBV or as a diagnostic test to confirm the presence of HBV infection. |
| P060022 9/5/08 |
Akreos™ Posterior Chamber Intraocular Lens | Bausch & Lomb Rochester, NY 14609 |
Approval for the Akreos™ Posterior Chamber Intraocular Lens (IOL), Model: Akreos™ Advanced Optics Aspheric Lens, AO60. The device is indicated for primary implantation for the visual correction of aphakia in adult patients where a cataractous lens has been removed by phacoemulsifi-cation. The lens is intended to be placed in the capsular bag. |
| P080004 9/26/08 |
Hoya iSpheric™ Model YA-60BB Intraocular Lens | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Approval for the Hoya iSpheric™ Model YA-60BB Intraocular Lens. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790017/S094 9/25/08 135-Day |
Gruntzig Dilaca Coronary Artery Balloon Dilation Catheters | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a move in component supplier location. |
| P790017/S097 9/11/08 180-Day |
NC Stormer Balloon Dilatation Catheter | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a manufacturing site located at Isotron PLC, Daventry, United kingdom, for e-beam sterilization. |
| P810002/S063 9/12/08 180-Day |
SJM Master HP™ Valved Graft with Gelweave Valsalva Technology, Model VAVGJ-515 | St. Jude Medical Cardiovascular Division St. Paul, MN 55117 |
Approval for a manufacturing site located at St. Jude Puerto Rico, Caguas, Puerto Rico. |
| P840001/S111 9/12/08 135-Day |
Synergy Family of Neurostimulation Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for multiple manufacturing process changes. |
| P850035/S033 9/18/08 180-Day |
SpF® PLUS-Mini (60uA/W) and SpF® PLUS-Mini (60uA/M) | Biomet, Inc., Parsippany, NJ 07054 |
Approval for a change in the trade name which was previously approved as: SpF®-PLUS (60/W) and SpF®- PLUS (60/M). The device will be marketed under the trade name SpF® PLUS-Mini (60uA/W) and SpF® PLUS-Mini (60uA/M) and is indicated as a spinal fusing adjunct to increase the probability of fusion success in 1 or 2 levels. |
| P860004/S100 9/3/08 Special |
Synchromed II Infusion System | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for labeling changes for intrathecal catheter models 8709SC, 8731SC, 8578 and 8596SC. |
| P880006/S060 9/9/08 Real-Time |
Sensolog/Dialog/ Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P880086/S166 9/9/08 Real-Time |
Affinity/Integrity/ Victory Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P880091/S028 9/10/08 135-Day |
STAAR, Surgical Elastic®, Elastimide®, and Elastic® Toric UV Absorbing Posterior Chamber IOLs | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for adding in house Limulus Amebocyte Lysate testing. |
| P900022/S011 9/10/08 Real-Time |
Programmer Application Software Package Version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers | ELA Medical, Inc, Plymouth, MN 55441 |
Approval for the Programmer Application software package version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers. |
| P900056/S093 9/30/08 135-Day |
Rotablator™ Rotational Angioplasty System RotaLink™ Exchangeable Catheter | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Approval for a manufacturing process change to eliminate a parts cleaning process for select components. |
| P910023/S184 9/9/08 Real-Time |
Cadence Family of ICD’s | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P910023/S188 9/4/08 Real-Time |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for an alternate high voltage charging transformer and associated minor design changes to the HVPCB for the Current and Promote ICDs/CRT-Ds. |
| P910077/S091 9/5/08 Real-Time |
Latitude™ Communicator Software & System Software Models: 6482 and 6488 | Guidant Corporation St. Paul, MN 55112 |
Approval for changes to the Latitude Regulated Application Software on Latitude System Server (Model 6488, Version 5.0). |
| P930038/S052 9/26/08 180-Day |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Cardiovascular Division Maple Gove, MN 55311 |
Approval for use of the Angio-Seal™ Vascular Closure Device in closure of femoral venous puncture sites and for the removal of the precaution statement relating to the use of the anticoagulant Warfarin. The device, as modified, will be marketed under the trade name Angio-Seal™ Vascular Closure Device and is indicated for use in closing and in reducing time to hemostasis at the femoral arterial and femoral venous puncture site in patients who have undergone diagnostic angiography or percutaneous transluminal coronary angioplasty (PTCA) procedures using an 8 French or smaller procedural sheath. |
| P950020/S013 9/29/08 180-Day |
Flextome™ Cutting Balloon™ Monorail™ (MR) and Over-the-Wire (OTW) PTCA Catheters | Boston Scientific Corporation San Diego, CA 92123 |
Approval for manufacturing sites located at Boston Scientific Corporation, in Maple Grove, Minnesota and Plymouth, Minnesota for the manufacture of the balloon component of the device. |
| P950020/S014 9/29/08 180-Day |
Flextome™ Cutting Balloon™ Monorail™ (MR) and Over-the-Wire (OTW) PTCA Catheters | Boston Scientific Corporation San Diego, CA 92123 |
Approval for manufacturing sites located at Boston Scientific Corporation, in Maple Grove, Minnesota and Plymouth, Minnesota for the manufacture of the blade (atherotomes) and mounted balloon/blade subassembly for the device. |
| P950020/S015 9/29/08 180-Day |
Flextome™ Cutting Balloon™ Monorail™ (MR) and Over-the-Wire (OTW) PTCA Catheters | Boston Scientific Corporation San Diego, CA 92123 |
Approval for manufacturing sites located at Boston Scientific Corporation, in Maple Grove, Minnesota and Plymouth, Minnesota for the Ultra2™ balloon subassembly manufacturing processes. |
| P950022/S052 9/18/09 Real-Time |
Durata Lead Family | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar, CA 91432 |
Approval for a labeling change to add a precaution against use of Durata leads with the St. Jude Medical Seal Away Valve. |
| P950029/S036 9/10/08 Real-Time |
Programmer Application Software Package Version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers | ELA Medical, Inc, Plymouth, MN 55441 |
Approval for the Programmer Application software package version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers. |
| P970008/S038 9/2/08 180-Day |
Urologix Targix® System | Urologix, Inc. Minneapolis, MN 55447 |
Approval for the addition of the CTC Advance™ Microwave Catheter 2.5-3.5 cm (model number TV1321C). |
| P970013/S027 9/9/08 Real-Time |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P970029/S012 9/11/08 Special |
Solargen 2100s Laser | Cardiogenesis Corporation Irvine, CA 92618 |
Approval for modifications to the Solargen 2100s Laser user manual. |
| P980003/S021 9/19/08 180-Day |
Chilli Cooled Ablation System | Boston Scientific Corp. San Jose, CA 95134 |
Approval for labeling changes resulting from completion of the condition of approval study. |
| P980022/S033 9/24/08 Real-Time |
CareLink™ Personal Therapy Management Software for Diabetes (MMT-7333) | Medtronic MiniMed, Inc. Northridge, CA 91325 |
Approval for a change to the CareLink Personal Therapy Management Software for Diabetes (MMT-7333) The CareLink Personal Therapy Management Software for Diabetes is a network based software system residing on a computer server platform connected to the Internet. The purpose of this system is to take information transmitted from insulin pumps, continuous glucose monitors and glucose meters, and logbook data entered by the patient, and turn it into Medtronic CareLink Therapy Management Software for Diabetes reports. The reports provide information that can be used to identify trends and track daily activities; such as carbohydrates eaten, meal time, insulin delivery, and blood glucose readings. The software version 4.6 is a revision to implement several feature enhancements, which include a Logbook Diary Report, removal of Roche ACCU-CHECK 'Aviva' and Compact Plus meters from meter listings displayed for users located in countries other than U.S. and Canada, and consolidation of the Help system that serves as Instructions for Use. |
| P980049/S037 9/10/08 Real-Time |
Programmer Application Software Package Version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers | ELA Medical, Inc, Plymouth, MN 55441 |
Approval for the Programmer Application software package version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers. |
| P990013/S013 9/26/08 Special |
STAAR, Surgical Collamer® Ultraviolet Absorbing Posterior Chamber Intraocular Lens | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for changes to the labeling. |
| P990013/S022 9/10/08 135-Day |
STAAR, Surgical Collamer® Ultraviolet Absorbing Posterior Chamber Intraocular Lens | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for adding in house Limulus Amebocyte Lysate testing. |
| P990020/S032 9/11/08 180-Day |
AneuRx Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a manufacturing site located at Isotron PLC, Daventry, United kingdom, for e-beam sterilization. |
| P990046/S018 9/11/08 135-Day |
ATS Mechanical Heart Valves | ATS Medical Minneapolis, MN 55447 |
Approval for changing the sterile product release process. |
| P000006/S011 9/16/08 Real-Time |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for changes to the “Shelf Life Program for the Titan Inflatable Penile Prosthesis – 60° C Accelerated and Real Time Aging” (i.e., shelf life testing protocol; document “MUS 085:065”), updated to incorporate the test parameters for the One-Touch Release (OTR) Pump. |
| P000026/S001 9/10/08 135-Day |
STAAR, Surgical Aquaflow® Collagen Glaucoma Drainage Device | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for adding in house Limulus Amebocyte Lysate testing. |
| P000029/S049 9/11/08 Special |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Approval for a revised specification for the phosphate buffer concentrate, including the test methods for pH determination and endotoxin determination as part of the specification. |
| P010014/S020 9/18/08 135-Day |
Oxford® Meniscal Unicompartmental Knee (Oxford® Partial Knee System) | Biomet Manufacturing Corporation Warsaw, IN 46581 |
Approval for a change in cleaning agent used in the intermediate wash process. |
| P020004/S034 9/24/08 135-Day |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86003 |
Approval for no longer monitoring a device manufacturing specification. |
| P020014/S020 9/11/08 Real-Time |
Conceptus Essure® System for Permanent Birth Control | Conceptus, Inc. Mountain View, CA 94041 |
Approval for a modification to specifications of the Dry Flow Introducer and the addition of a back-up bond in the detachment mechanism. |
| P020031/S003 9/2/08 180-Day |
Microsulis Microwave Endometrial Ablation (MEA) System | Microsulis Medical Ltd. Hants, K PO7 6XP |
Approval for modifications to the Instructions for Use for the MEA System to include the results of the long-term follow-up of study subjects. |
| P030009/S019 9/25/08 135-Day |
Driver and Micro-Driver Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a move in component supplier location. |
| P030009/S021 9/22/08 135-Day |
Driver Rapid Exchange (RX) Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for an alternate manufacturing site for a subassembly component. |
| P030009/S023 9/11/08 180-Day |
Driver and Micro-Driver Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a sterilization site located at Isotron PLC, Daventry, United Kingdom, for e-beam sterilization. |
| P030009/S026 9/11/08 135-Day |
Driver and Micro-Driver Coronary Stent System | Medtronic Vascular Santa Rose, CA 95403 |
Approval for the introduction of additional automation to the balloon sub-assembly manufacturing process for the device. |
| P030016/S009 9/10/08 135-Day |
STAAR, Surgical Implantable Collamer Lens for Myopia | STAAR Surgical Co. Monrovia, CA 91016 |
Approval for adding in house Limulus Amebocyte Lysate testing. |
| P030017/S055 9/5/08 135-Day |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Approval for revisions to sterilization process instructions. |
| P030025/S021 9/24/08 180-Day |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW), 2.25 and 4.0 mm | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for stent diameters which expand the product matrix to include 2.25 mm and 4.0mm TAXUS Express2 Paclitaxel-Eluting Coronary Stent Systems. The device, as modified, will be marketed under the trade name TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) and is indicated for the following: The TAXUS Express Paclitaxel-Eluting Coronary Stent System is indicated for improving Luminal diameter for the treatment of de novo lesions in native coronary arteries >2.25 to <4.0mm in diameter in lesions < 28mm in length. |
| P030025/S028 9/24/08 Panel |
TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) – In-Stent Restenosis (ISR) Indication | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for the TAXUS™ Express 2™ Paclitaxel-Eluting Coronary Stent System – In-Stent Restenosis (ISR) Indication. The device is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries >=2.25 to <=4.00 mm in diameter in lesions <=28 mm in length, and within bare metal stent restenotic lesions >=2.25 to <=3.75 mm in diameter and <=28 mm in length. |
| P030031/S009 9/30/08 180-Day |
EZ Steer ThermoCool and EZ Steer ThermoCool Nav Diagnostic/Ablation Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for incorporation of a bidirectional deflection mechanism in the NaviStar ThermoCool and Celsius ThermoCool Catheters. The device, as modified, will be marketed under the trade name EZ Steer ThermoCool and Ez Steer ThermoCool Nav Catheters and indicated for treatment of type I atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia. |
| P030035/S045 9/9/08 Real-Time |
Frontier/Frontier II Family of CRT-P’s | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P030039/S011 9/26/08 Special |
CoSeal® Surgical Sealant, Premixed | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for addition of safety related statements to the labeling. |
| P030047/S011 9/30/08 135-Day |
Cordis PRECISES® Nitinol Stent System, PRECISE® RX Nitinol Stent System, and PRECISE® PRO Rx™ Nitinol stent System | Cordis CORPORATION Warren, NJ 07059 |
Approval for reducing the sample size for the following processes: 1) the fusing operation for all PRECISE devices and the sealing operation for PRECISE RX; and 2) the bonding process of the PRECISE RX and PRECISE PRO Rx Support Member/Wire Lumen subassembly. |
| P030047/S012 9/10/08 135-Day |
Cordis PRECISES® Nitinol Stent System | Cordis CORPORATION Warren, NJ 07059 |
Approval for a change to the incoming inspection specifications for the raw material used for the hypotube component. |
| P030054/S099 9/9/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for the Model 3330 Version 6.9.1 Software for use on the Model 3650 Merlin Patient Care System. |
| P030054/S103 9/4/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 91342 |
Approval for an alternate high voltage charging transformer and associated minor design changes to the HVPCB for the Current and Promote ICDs/CRT-Ds. |
| P040013/S012 9/3/08 180-Day |
GEM21s (Growth Enhanced Matrix) | Luitpold Pharmaceuticals Franklin, TN 37067 |
Approval of the post-approval study. |
| P040021/S007 9/26/08 180-Day |
SJM Biocor 25mm mitral valve size and the Epic 25 mm mitral valve size | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the SJM Biocor 25mm mitral valve size and the Epic 25 mm mitral valve size. |
| P040024/S023 9/29/08 180-Day |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Approval for a change in product labeling that included information regarding increased duration of device effectiveness. |
| P40036/S006 9/30/08 |
EZ Steer ThermoCool and EZ Steer ThermoCool Nav Diagnostic/Ablation Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for incorporation of a bidirectional deflection mechanism in the NaviStar ThermoCool and Celsius ThermoCool Catheters. The device, as modified, will be marketed under the trade name EZ Steer ThermoCool and Ez Steer ThermoCool Nav Catheters and indicated for treatment of type I atrial flutter and recurrent drug/device refractory sustained monomorphic ventricular tachycardia. |
| P040047/S001 9/29/08 180-Day |
Coaptite® Injectable Implant | Bioform Medical, Inc. Franksville, WI 53126 |
Approval of the post-approval study. |
| P060002/S003 9/23/08 Special |
FLAIR™ Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85280 |
Approval to add a specification and inspection procedure tor the Y-injection-adapter component. |
| P060027/S001 9/10/08 Real-Time |
Programmer Application Software Package Version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers | ELA Medical, Inc, Plymouth, MN 55441 |
Approval for the Programmer Application software package version Smartview 2.02 UG4 for Orchestra and Orchestra Plus Programmers. |
| P060033/S002 9/25/08 135-Day |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a move in component supplier location. |
| P060033/S013 9/16/08 180-Day |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study. |
| P070007/S002 9/3/08 180-Day |
Talent™ Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study. |
| P070009/S001 9/9/08 180-Day |
Swedish Adjustable Gastric Band | Obtech Medical Cincinnati, OH 45242 |
Approval of the post-approval study. |
| P070013/S002 9/15/08 180-Day |
EVOLENCE® Collagen Filler | Colbar Lifescience Ltd. Skillman, NJ 08558 |
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 |
|---|---|---|---|
| P790018/S049 9/9/08 |
Medtronic Hall™ Prosthetic Heart Valve; Hall Easy-Fit® Prosthetic Heart Valve; Medtronic Hall™ Rotatable Aortic Valved Collagen Impregnated Conduit | Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Change in vendor for a suture used in the manufacture of the devices. |
| P810031/S036 9/19/08 |
Vitrax/Healon D Sodium Hyaluronate Solution Ophthalmic Viscosurgical Devices, Healon, Healon GV, and Healon5 Sodium Hyaluronate Ophthalmic Viscosurgical Devices | Advanced Medical Optics Santa Ana, CA 92705 |
Implementation of a new water system. |
| P840001/S119 9/17/08 |
Restore Ultra Implantable Neurostimulator, Model 37712 | Medtronic, Inc. Minneapolis, MN 55432 |
Change to qualify a second vendor. |
| P860004/S101 9/30/08 |
SynchroMed II Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change of a manual process to an automated process, and a change of manufacturing equipment where the specifications of the equipment are unchanged. |
| P860019/S228 9/26/08 |
Quantum Maverick and Maverick OTW PTCA Catheter | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Change to the method that is used to create the proximal marks, three white circumferential markings, located on the shaft of the catheter. |
| P880003/S095 9/30/08 |
DURA STAR™ Rx PTCA Balloon Dilatation Catheter | Cordis Corporation Warren, NJ 07059 |
Changes to the manufacturing process to address the potential for slow or no deflation of the device. |
| P880031/S015 9/19/08 |
Vitrax/Healon D Sodium Hyaluronate Solution Ophthalmic Viscosurgical Devices, Healon, Healon GV, and Healon5 Sodium Hyaluronate Ophthalmic Viscosurgical Devices | Advanced Medical Optics Santa Ana, CA 92705 |
Implementation of a new water system. |
| P900023/S050 9/18/08 |
ABIOMED Arterial Cannula | Abiomed, Inc. Danvers, MA 01923 |
Change from a coating procedure performed at an outside vendor to a coating procedure performed at ABIOMED. |
| P900061/S078 9/10/08 |
GEM and GEM II VR | Medtronic, Inc. Mounds View, MN 55112 |
Addition fo an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P910023/S186 9/10/08 |
Current Family of Implantable Cardioverter Defibrillators (ICDs) | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Alternate vendor for a hybrid component. |
| P910023/S187 9/10/08 |
Cadence RF Module | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in the rework process and the addition of a new piece of equipment. |
| P960028/S030 9/30/08 |
ReZoom Multifocal Acrylic Intraocular Lens, Model NXG1 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sheet casting process for manufacturing the device. |
| P960040/S176 9/26/08 |
Vitality and Vitality 2 |
Guidant Corporation St. Paul, MN 55112 |
Addition of an alternative adhesive for the digital application-specific integrated circuit (ASIC). |
| P960043/S064 9/12/08 |
Suture Mediated Closure (SMC) System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Modification to the sterilization cycle for the device. |
| P970012/S041 9/10/08 |
Kappa 400 DR; Kappa 400SR | Medtronic, Inc. Mounds View, MN 55112 |
Addition fo an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P970012/S042 9/11/08 |
Kappa 400 SR Family of Pulse Generators (PGs) | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Changes to the battery burn-in process. |
| P970020/S052 9/3/08 |
Multi-Link OTW Zeta® Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in radiation equipment used in the manufacture of the device. |
| P970021/S023 9/19/08 |
The Gynecare Thermachoice™ III | Ethicon, Inc., Women’s Health and Urology Somerville, NJ 08876 |
Use of an additional sterilization chamber, which is located in the currently approved manufacturing facility. |
| P970031/S024 9/9/08 |
Freestyle® Aortic Root Bioprosthesis | Medtronic Cardiac Surgery Minneapolis, MN 55432 |
Change in vendor for a suture used in the manufacture of the devices. |
| P970034/S011 9/12/08 |
UV Absorbing Posterior Chamber Intraocular Lens | Ophthalmic Innovations, International, Inc. Ontario, CA 91761 |
Changes to the tumbling process. |
| P970034/S012 9/18/08 |
UV Absorbing Posterior Chamber Intraocular Lens | Ophthalmic Innovations, International, Inc. Ontario, CA 91761 |
Change in blocking wax formulation. |
| P970051/S047 9/5/08 |
Nucleus Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Integration of the welding process and the addition of a second welding system for the CI24R and CI24R devices. |
| P980016/S147 9/4/08 |
Maximo II DR /VR | Medtronic, Inc. Mounds View, MN 55112 |
Change in manufacturing to modify the Maximo II Device’s memory files. |
| P980016/S148 9/10/08 |
GEM DR; GEM II Family; GEM III DR/VR Family; Onyx Family; Marquis Family; Maximo Family; Intrinsic Family; EnTrust Family; Virtuoso Family; Secura DR/VR Family; Maximo II DR/VR Family | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P980016/S149 9/10/08 |
Virtuoso Family, EnTrust Family, Maximo II and Secura | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of existing, obsolete epoxy dispenser with new equipment. |
| P980035/S110 9/10/08 |
Kappa 600/700, 650, 800/900 Family; Sigma Family; EnPulse II Family; Medtronic 350 Series; EnRhythm IPG; AT501 System; Adapta/Versa/ Sensia Family | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P980035/S111 9/11/08 |
Adapta, Sensia, Versa, Kappa 700/800/900, and EnPulse E2 Family of Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Changes to the battery burn-in process. |
| P980035/S112 9/17/08 |
Kappa 600/700, 650, 800/900 Family, Sigma Family, Medtronic 350 Series, EnPulse II Family, and Adapta/Versa/ Sensia Family | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Replacement of existing, obsolete epoxy dispenser with new equipment. |
| P980040/S025 9/30/08 |
Sensar Soft Acrylic Intraocular Lenses, Models AR40e, AR40E, and AR40MN and Tecnis One-Piece Soft Acrylic Intraocular Lenses, Models ACB00 and AAB00 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sheet casting process for manufacturing the device. |
| P980050/S036 9/10/08 |
GEM II AT | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P990001/S042 9/10/08 |
Dema Family (Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita II DDDR and Vita II), Diva Family (Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD and Vita VVIR); C-series Devices; T-series Devices |
Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P990001/S043 9/17/08 |
C-series Devices and T-series Devices | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Replacement of existing, obsolete epoxy dispenser with new equipment. |
| P990012/S007 9/23/08 |
Elecsys HBsAg Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Change in the quality control testing method used to determine the biotin binding capacity of the Elecsys microparticle beads used in the two assays. |
| P990013/S023 9/4/08 |
STAAR® Surgical Collamer UV – Absorbing Posterior Chamber Intraocular Lens | STAAR® Surgical Monrovia, CA 91016 |
Change to the model of silicone/Teflon septa currently used to manufacture Collamer™ lenses at the Nidau, Switzerland facility. |
| P990056/S009 9/17/08 |
Elecsys Total PSA | Roche Diagnostics Indianapolis, IN 46250 |
Change in the quality control testing method used to determine the biotin binding capacity of the Elecsys microparticles (beads). |
| P990074/S019 9/19/08 |
Allergan Silicone-Filled Breast Implants | Allergan Goleta, CA 93117 |
Change in the suppliers of certain components of the device. |
| P990080/S031 9/30/08 |
Tecnis Acrylic Intraocular Lens, Model ZA9003 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the sheet casting process for manufacturing the device. |
| P000027/S007 9/17/08 |
Elecsys Free PSA | Roche Diagnostics Indianapolis, IN 46250 |
Change in the quality control testing method used to determine the biotin binding capacity of the Elecsys microparticles (beads). |
| P010015/S051 9/10/08 |
InSync Pulse Generator; InSync III | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P010027/S001 9/12/08 |
Anterior Chamber Intraocular Lens | Ophthalmic Innovations, International, Inc. Ontario, CA 91761 |
Changes to the tumbling process. |
| P010027/S002 9/18/08 |
Anterior Chamber Intraocular Lens | Ophthalmic Innovations, International, Inc. Ontario, CA 91761 |
Change in blocking wax formulation. |
| P010031/S116 9/4/08 |
Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Change in manufacturing to modify the Maximo II Device’s memory files. |
| P010031/S117 9/10/08 |
InSync CRT-D; InSync Marquis; InSync II Marquis Family; InSync III Marquis Family; InSync II Protect; InSync Sentry Family; InSync Maximo Family; Concerto; Consulta; Maximo II | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an EtO sterilizer at the Tolochenaz, Switzerland facility and changes to the ethylene oxide sterilization lethality model. The addition of the EtO sterilizer is not applicable to the following devices: Consulta, Maximo II, Secura DR/VR family, and Maximo II DDR/VR family. |
| P010031/S118 9/17/08 |
Concerto, Maximo II and Consulta | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Replacement of existing, obsolete epoxy dispenser with new equipment. |
| P010054/S010 9/23/08 |
Elecsys Anti-HBs Immunoassay | Roche Diagnostics Indianapolis, IN 46250 |
Change in the quality control testing method used to determine the biotin binding capacity of the Elecsys microparticle beads used in the two assays. |
| P020009/S046 9/26/08 |
Express2™ OTW Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Change to the method that is used to create the proximal marks, three white circumferential markings, located on the shaft of the catheter. |
| P020026/S057 9/12/08 |
CYPHER® Sirolimus-eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System or RAPTORRAIL® Rapid Exchange Delivery System (CYPHER® Stent) | Cordis Corporation Miami Lakes, FL 33014 |
Extension of the shelf-life of a component of the device. |
| P020047/S012 9/3/08 |
Multi-Link Vision® OTW Family of Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in radiation equipment used in the manufacture of the device. |
| P020056/S007 9/12/08 |
Allergan Silicone-Filled Breast Implant | Allergan Goleta, CA 93117 |
Change in the supplier of certain components of the device. |
| P030002/S017 9/5/08 |
Crystalens® Model AT-45 Accommodating Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Addition of an alternate optical comparator. |
| P030005/S054 9/26/08 |
Contak Renewal TR | Guidant Corporation St. Paul, MN 55112 |
Addition of an alternative adhesive for the digital application-specific integrated circuit (ASIC). |
| P030016/S010 9/4/08 |
STAAR® Surgical Collamer UV – Absorbing Posterior Chamber Intraocular Lens | STAAR® Surgical Monrovia, CA 91016 |
Change to the model of silicone/Teflon septa currently used to manufacture Collamer™ lenses at the Nidau, Switzerland facility. |
| P030017/S072 9/30/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Change to the welding process for the spring contacts. |
| P030017/S073 9/30/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Change from a manual to an automated SCSII Remote Control functional testing process. |
| P030017/S077 9/30/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Change to add solder to the digital shield of the External Trial Stimulator. |
| P030017/S079 9/30/08 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Changes to the Connector Stack Assembly process. |
| P030025/S058 9/26/08 |
TAXUS™ Express2 OTW Paclitaxel Eluting Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Change to the method that is used to create the proximal marks, three white circumferential markings, located on the shaft of the catheter. |
| P030054/S101 9/10/08 |
Promote Family of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Alternate vendor for a hybrid component. |
| P030054/S102 9/10/08 |
Epic HF Module | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change in the rework process and the addition of a new piece of equipment. |
| P040008/S001 9/25/08 |
VIDAS® Total PSA (TPSA) Assay | bioMérieux, Inc. Hazelwood, MO 63042 |
Change of vendor for the mouse monoclonal antibody used in the manufacture of the device. |
| P040016/S033 9/26/08 |
Liberté™ OTW Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Change to the method that is used to create the proximal marks, three white circumferential markings, located on the shaft of the catheter. |
| P040047/S008 9/2/08 |
Coaptite® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Installation of additional packaging equipment used to manufacture the device. |
| P050007/S011 9/12/08 |
StarClose Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Modification to the sterilization cycle for the device. |
| P050007/S012 9/19/08 |
StarClose Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Change to automate a currently manual process. |
| P050038/S008 9/26/08 |
Arista AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Change from a manual method for assembling the device to an automated method. |
| P070015/S004 9/5/08 |
XIENCE V™ RX Everolimus Eluting Coronary Stent System | Abbott Vascular, Inc. Temecula, CA 92591 |
Change in the e-beam irradiation equipment used during the manufacturing of the device. |
| P070015/S005 9/9/08 |
XIENCE V™ RX Everolimus Eluting Coronary Stent System (EECSS) | Abbott Vascular, Inc. Temecula, CA 92591 |
Change from a manual coiling process to an automated coiling process in the manufacture of the EECSS. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 64
Summary of PMA Originals Under Review
Total Under Review: 74
Total Active: 30
Total On Hold: 44
Number Greater Than 180 Days: 7
Summary of PMA Supplements Under Review
Total Under Review: 526
Total Active: 366
Total On Hold: 160
Number Greater Than 180 Days: 16
Summary of All PMA Submissions Received
Originals: 1
Supplements: 157
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 64
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 207.9
FDA Time: 98.6 Days MFR Time: 109.3 Days
Updated October 20, 2008
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