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Medical Devices

2003 Device Approvals

The products listed below contain information about what medical uses the device is approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Approved by FDA in 2003

2003 Device Approvals

Device NameCategoryDate
CoSeal™ Surgical Sealant - P030039 [ARCHIVED] Vascular Sealant 12/12/03
Restylane™ Injectable Gel - P020023 [ARCHIVED] Wrinkle Filler 12/12/03
Keramos™ Ceramic/Ceramic Total Hip System - D980003 [ARCHIVED] Hip Prosthesis 11/26/03
Contegra® Pulmonary Valved Conduit, Models 200 (unsupported) and 200S (supported) - H020003 [ARCHIVED] Heart Valve 11/21/03
CrystaLens™ Model AT-45 Accommodating IOL - P030002 [ARCHIVED] Itraocular Lens (IOL) 11/14/03
NIRflex™ Premounted Coronary Stent System - P020040 [ARCHIVED] Stent 10/24/03
Morcher Endocapsular Tension Ring - P010059 [ARCHIVED] Intraocular Lens (IOL) 10/23/03
WaveLight ALLEGRETTO WAVE™ Excimer Laser System - P030008 [ARCHIVED] LASIK 10/13/03
WaveLight ALLEGRETTO WAVE™ Excimer Laser System - P020050 [ARCHIVED] LASIK 10/07/03
Microwave Endometrial Ablation (MEA) System – P020031 [ARCHIVED] Ablation Device 09/23/03
Blazer II XP Cardiac Ablation Catheter, EPT-1000 XP Cardiac Ablation Controller and Accessories - P020025 [ARCHIVED] Ablation Catheter 08/25/03
INDEPENDENCE™ iBOT™ 3000 Mobility System – P020033 [ARCHIVED] Wheelchair 08/13/03
S.M.A.R.T.™ Nitinol Stent System / S.M.A.R.T.™ Control™ Nitinol Stent System - P020036 [ARCHIVED] Stent 08/12/03
MULTI-LINK VISION™ RX & OTW Coronary Stent System - P020047 [ARCHIVED] Stent 07/16/03
FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty PTCA Catheter - P020037 [ARCHIVED] Angioplasty Catheter 06/11/03
ThinPrep™ Imaging System - P020002 [ARCHIVED] Imaging System 06/06/03
Zenith® AAA Endovascular Graft - P020018 [ARCHIVED] Vascular Graft 05/23/03
Response™ CV Catheter System - P020052 [ARCHIVED] Cardiac Catheter 05/07/03
CYPHER™ Sirolimus-eluting Coronary Stent - P020026 [ARCHIVED] Stent 04/24/03
7F Freezor® Cardiac Cryoablation Catheter and CCT.2 CryoConsole System - P020045 [ARCHIVED] Ablation Devices 04/17/03
Medtronic Activa® Dystonia Therapy - H020007 [ARCHIVED] Brain Stimulator 04/15/03
Digene Hybrid Capture 2 High-Risk HPV DNA Test - P890064 S009 A004 [ARCHIVED] Cervical Cancer Test 03/31/03
Bayer Versant™ HCV RNA 3.0 Assay (bDNA) – P020022 [ARCHIVED] Hepatitis Test 03/28/03
FemCap™ - P020041 [ARCHIVED] Contraceptive 03/28/03
Medtronic AT500TM DDDRP Pacing System - P980035/S13 [ARCHIVED] Pacemaker 03/26/03
NeedleZap™ - P010065 [ARCHIVED] Needle-Destruction Device 03/14/03
CosmoDerm™ 1 Human-Based Collagen, CosmoDerm™ 2 Human-Based Collagen and CosmoPlast™ Human-Based Collagen - P800022/S050 [ARCHIVED] Wrinkle Filler 03/11/03
Ceramic TRANSCEND® Hip Articulation System - P010001 [ARCHIVED] Hip Prosthesis 02/03/03
Osteonics® ABC System and Trident™ System – P000013 [ARCHIVED] Hip Prosthesis 02/03/03
Dimension® Free Specific Antigen (FPSA) Flex® Reagent Cartridge - P020027 [ARCHIVED] PSA Test 01/24/03
Philips Series 50 XMO Fetal/Maternal Monitor (Model M1350C) with Integrated Fetal Oxygen Saturation Monitoring - P020028 [ARCHIVED] Fetal Monitor 01/03/03

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