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Medical Devices

2002 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 2002

2002 Device Approvals

Device NameCategoryDate
ProstaLund® Core Therm™ [ARCHIVED] BPH Treatment 12/23/02
Bridge™ Extra Support Over-The-Wire Renal Stent System - P020007 [ARCHIVED] Stent 12/18/02
Metrika A1cNow® for Home Use - K022661 [ARCHIVED] Diabetes Test 12/13/02
Karl Storz Autofluorescence System - P020008 [ARCHIVED] Bronchoscope 12/12/02
ALERT® System - P990069 [ARCHIVED] Defibrillator 11/27/02
Elecsys® proBNP Immunoassay - K022516 [ARCHIVED] Heart Failure Test 11/19/02
IDI-Strep B Assay - K022504 [ARCHIVED] Strep Test 11/18/02
EXCLUDER™ Bifurcated Endoprosthesis - P020004 [ARCHIVED] Vascular Graft 11/16/02
HeartMate® SNAP-VE LVAS - P920014/S016 [ARCHIVED] LVAD 11/06/02
VERSANT™ HCV RNA Qualitative Assay - P020011 [ARCHIVED] Hepatitis Test 11/07/02
Essure™ System - P020014 [ARCHIVED] Contraceptive 11/04/02
NaviStar DS and Celsius DS Diagnostic/Ablation Catheters, Stockert 70 RF Generator and accessories – P010068 [ARCHIVED] Ablation Catheter 09/27/02
Neuroform™ Microdelivery Stent System - H020002 [ARCHIVED] Stent 09/11/02
GlucoWatch G2 Biographer - P990026/S0008 [ARCHIVED] Glucose Monitor 08/26/02
RetroX Transcutaneous Air Conduction Hearing Aid System - K013298 [ARCHIVED] Hearing Aid 08/20/02
NEUROLINK® System - H010004 [ARCHIVED] Stent 08/09/02
IMMULITE® HBsAg and IMMULITE® 2000 HBsAg and Confirmatory Kit - P010050 [ARCHIVED] Hepatitis Test 07/26/02
IMMULITE® Anti-HBc IgM and IMMULITE® 2000 Anti-HBc IgM - P010053 [ARCHIVED] Hepatitis Test 07/26/02
IMMULITE® Anti-HBc and IMMULITE® 2000 Anti-HBc - P010051 [ARCHIVED] Hepatitis Test 07/24/02
IMMULITE® Anti-HBs and IMMULITE® 2000 Anti-HBs - P010052 [ARCHIVED] Hepatitis Test 07/22/02
Mentor Saline-Filled Testicular Prosthesis - P020003 [ARCHIVED] Testicular Prostheses 07/19/02
SONOCUR® - P010039 [ARCHIVED] Shock Wave Therapy 07/19/02
Expanded Use of Guidant Ventak Implantable Cardioverter Defibrillators - P910077 S037 [ARCHIVED] Defibrillator 07/18/02
PALMAZ® Balloon-Expandable Stent for Renal Arteries - P890017/S10 [ARCHIVED] Stent 07/10/02
InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device - P000058 [ARCHIVED] Spinal Implant 07/02/02
Medtronic® InSync® ICD Model 7272 Dual Chamber Implantable Cardioverter Defibrillator System with Cardiac Resynchronization Therapy - P010031 [ARCHIVED] Defibrillator 06/26/02
AFFINITY™ Cage System - P000028 [ARCHIVED] Spinal Implant 06/13/02
Paragon CRT™ (paflufocon B), Paragon CRT ™100 (paflufocon D), Paragon Quadra RG ™(paflufocon B), and Paragon Quadra RG ™100 (paflufocon D) Rigid Gas Permeable Contact Lenses for Overnight Wear- P870024S043 [ARCHIVED] Contact Lens 06/13/02
Roche Diagnostics Accu-Check® Advantage® Module - K021513 [ARCHIVED] Glucose Monitor 06/11/02
TheraSense, Inc. FreeStyle Tracker™ Diabetes Management System - K020866 [ARCHIVED] Glucose Monitor 06/11/02
Indermil™ Tissue Adhesive - P010002 [ARCHIVED] Skin Adhesive 05/22/02
Guidant Cardiac Resynchronization Therapy Defibrillator System including the CONTAK CD® pulse generator and the EASYTRAK® left ventricular coronary venous lead - P010012 [ARCHIVED] Defibrillator 05/02/02
Ancure® Aortoiliac System - P990017/S030 [ARCHIVED] Endovascular Graft 04/24/02
INTEGRA® Dermal Regeneration Template - P900033/S008 [ARCHIVED] Skin Repair 04/19/02
ViewPoint™ CK System - P010018 [ARCHIVED] Keratoplasty Device 04/11/02
IntraCoil® Self-Expanding Peripheral Stent - P000033 [ARCHIVED] Stent 04/03/02
QuickSeal Arterial Closure System - P010049 [ARCHIVED] Vascular Sealant 03/25/02
Disintegrator™Insulin Needle Destruction Unit - P010040 [ARCHIVED] Needles Destruction Device 03/15/02
Lorad Digital Breast Imager - P010025 [ARCHIVED] Mammography 03/15/02
Lea's Shield® - P010043 [ARCHIVED] Contraceptive 03/14/02
SIR-Spheres®- P990065 [ARCHIVED] Cancer Injection 03/05/02
Roche Elecsys® Anti-HBs Immunoassay & Elecsys® PreciControl Anti-HBs - P010054 [ARCHIVED] Hepatitis Test 02/27/02
Wartner Wart Removal System K011708 [ARCHIVED] Wart Remover 02/20/02
Second Look™ - P010034 [ARCHIVED] Mammography 01/31/02
MammoReader - P010038 [ARCHIVED] Mammography 01/15/02
Activa® Parkinson's Control System P960009/S7 [ARCHIVED] Brain Stimulator 01/14/02

Page Last Updated: 09/05/2013
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