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Medical Devices

2001 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

2001 Device Approvals

Device NameCategoryDate
VISX Excimer Laser System and Custom Contoured Ablation Pattern (C-CAP) Method™ - H000002 [ARCHIVED] Laser 12/19/01
Acticon™ Neosphincter - P010020 [ARCHIVED] Sphincter 12/18/01
LIFECOR Wearable Cardioverter Defibrillator (WCD®) 2000 System - P010030 [ARCHIVED] Defibrillator 12/18/01
CoSeal® Surgical Sealant - P010022 [ARCHIVED] Vascular Sealant 12/14/01
AMPLATZER® Septal Occluder - P000039 [ARCHIVED] Septal Occluder 12/05/01
NNMT Medical, Inc. CardioSEAL® Septal Occlusion System with QwikLoad™ - P000049 [ARCHIVED] Septal Occluders 12/05/01
CryoLife BioGlue Surgical Adhesive - P010003 [ARCHIVED] Skin Adhesive 12/03/01
QuantiFERON® -TB - P010033 [ARCHIVED] TB Test 11/28/01
Genesis Neurostimulation (IPG) System - P010032 [ARCHIVED] Stimulator 11/21/01
Ascension® MCP - P000057 [ARCHIVED] Finger Joint Prosthesis 11/19/01
GYNECARE INTERGEL® Adhesion Prevention Solution - P990015 [ARCHIVED] Adhesion Prevention 11/16/01
WALLSTENT® Venous Endoprosthesis with Unistep™ Plus Delivery System - P980033 [ARCHIVED] Stent 11/16/01
IMMULITE® AFP and IMMULITE® 2000 AFP - P010007 [ARCHIVED] Alpha-Fetoprotein Test 11/09/01
OP-1™ - H010002 [ARCHIVED] Bone Implant 10/17/01
Focus® Night and Day Soft Contact Lens - P010019 [ARCHIVED] Contact Lens 10/11/01
Home Monitoring System with the BA03 DDDR Pulse Generator - P950037/S19 [ARCHIVED] Pacemaker 10/11/01
DERMAGRAFT® - P000036 [ARCHIVED] Skin Repair 09/28/01
NovaSure™ Impedance Controlled Endometrial Ablation System - P010013 [ARCHIVED] Ablation Devices 09/28/01
SenoScan® Full Field Digital Mammography System - P010017 [ARCHIVED] Mammography 09/25/01
IDeflux® Injectable Gel - P000029 [ARCHIVED] Urinary Bulking Agent 09/24/01
Model 3100B High-Frequency Oscillatory Ventilator - P890057/S014 [ARCHIVED] Ventilator 09/24/01
SOUNDTEC® Direct Drive Hearing System - P010023 [ARCHIVED] Hearing Aid 09/07/01
OrCel™ Bilayered Cellular Matrix - P010016 [ARCHIVED] Skin Repair 08/31/01
Vitros Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator - P010021 [ARCHIVED] Hepatitis Test 08/30/01
Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis - H010001 [ARCHIVED] Finger Joint Prosthesis 08/28/01
Medtronic® InSync® Biventricular Pacing System including the InSync ®Model 8040 Pulse Generator, Attain™ LV Model 2187 and Attain ™CS Model 2188 Leads - P010015 [ARCHIVED] Pacemaker 08/28/01
MED-EL COMBI 40+ Cochlear Implant System - P000025 [ARCHIVED] Cochlear Implant 08/20/01
Given® Diagnostic Imaging System - K010312 [ARCHIVED] Camera 08/01/01
UBIS 5000 Ultrasound Bone Sonometer - P000055 [ARCHIVED] Bone Ultrasound 07/17/01
AquaFlow™ Collagen Glaucoma Drainage Device - Model CGDD-20 - P000026 [ARCHIVED] Glaucoma Device 07/12/01
RapidScreen™ RS-2000 - P000041 [ARCHIVED] Computer Aided Diagnosis 07/12/01
INTEGRITY™ AFx DR MODEL 5346 / P880086/S083 (Generator) & P830045/S076 (Programmer) [ARCHIVED] Pacemaker 07/11/01
AMPLICOR™ Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) P000010 [ARCHIVED] Hepatitis Test 07/05/01
Dimension RxL PSA Flex Reagent Cartridge - P000021 [ARCHIVED] PSA Test 07/05/01
COBAS AMPLICOR™ Hepatitis C Virus (HCV) Test, version 2.0 (v2.0) P000012 [ARCHIVED] Hepatitis Test 07/03/01
TMx-2000™ BPH Thermotherapy System - P000043 [ARCHIVED] Microwave Therapy 06/29/01
Carisolv Non-Invasive Caries Removal System - P000005 [ARCHIVED] Dental Treatment 06/27/01
Diagnostic Products Corporation's Total Prostate Specific Antgen (PSA) Assays on the Immulite and Immulite 2000 Analyzers - P930027/S4 [ARCHIVED] PSA Test 06/19/01
AMS Sphincter 800™ Urinary Prosthesis - P000053 [ARCHIVED] Sphincter 06/14/01
LAP-BAND® Adjustable Gastric Banding (LAGB®) System - P000008 [ARCHIVED] Obesity Treatment 06/05/01
Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory, and PreciControl HBsAg- P990012 [ARCHIVED] Hepatitis Test 06/01/01
On-X® Prosthetic Heart Valve - P000037 [ARCHIVED] Heart Valve 05/30/01
Heartstream FR2 AED with Attenuated Defibrillation Pads K003819 [ARCHIVED] Automated External Defibrillator (AED) 05/02/01
Vitros Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and HBsAg Confirmatory Kit - P000044 [ARCHIVED] Hepatitis Test 04/27/01
BAK/Cervical (BAK/C®) Interbody Fusion System - P980048 [ARCHIVED] Spinal Implant 04/20/01
HerOption™ Uterine Cryoblation Therapy™ System - P000032 [ARCHIVED] Ablation Device 04/20/01
STAARVISC™ Sodium Hyaluronate - P000046 [ARCHIVED] Eye Implant 04/18/01
Medtronic Model 7250 Jewel®AF Implantable Cardioverter Defibrillator System - P980050/S1 [ARCHIVED] Defibrillator 04/06/06
CeeOn™ Edge Foldable Intraocular Lens - Model 911A - P990080 [ARCHIVED] Intraocular Lens (IOL) 04/05/01
Devices For Testing The Hepatitis B Virus (HBV) [ARCHIVED] Hepatitis Test 03/30/01
Prostalac Hip Temporary Prosthesis - H000004 [ARCHIVED] Hip Prosthesis 03/23/01
GlucoWatch® Automatic Glucose Biographer - P990026 [ARCHIVED] Glucose Monitors 03/22/01
N Latex Cystatin C Test Kit - K003503 [ARCHIVED] Kidney Test 03/13/01
Edwards Prima™ Plus Stentless Bioprosthesis Model 2500P - P000007 [ARCHIVED] Heart Valve 02/27/01
TMJ Fossa Eminence Prosthesis™ - P000035 [ARCHIVED] Jaw Prosthesis 02/27/01
Composite Cultured Skin - H990013 [ARCHIVED] Skin Repair 02/21/01
VISTAKON (lenefilcon A) Soft Contact Lenses - P990085 [ARCHIVED] Contact Lens 02/16/01
Corometrics 120 F-Series Maternal/Fetal Monitor with Integrated Fetal Oxygen Saturation Monitoring - P000016 [ARCHIVED] Fetal Monitor 02/09/01
SUPARTZ™ DISPO- P980044 [ARCHIVED] Arthritis Treatment 01/24/01
TMJ (Temporomandibular Joint) Metal-on-Metal Total Joint Replacement Prostheses System - P000023 [ARCHIVED] Jaw Prosthesis 01/05/01

Page Last Updated: 09/05/2013
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