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Medical Devices

2000 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 2000

2000 Device Approvals

Device NameCategoryDate
Microny SR+ Cardiac Pacemaker (Model 245T) - P970013 [ARCHIVED] Pacemaker 12/21/00
Q-103 Needle Management System - P980020 [ARCHIVED] Needle Destruction Device 12/21/00
Roche Elecsys free Prostate-Specific Antigen (fPSA) Assay on the Elecsys 1010 and 2010 immunoassay analyzers (P000027) (Revised 2/28/01) [ARCHIVED] PSA Test 12/12/00
Psychemedics Corporation Opiate Assay - K000851 [ARCHIVED] Drugs of Abuse Test 12/11/00
Stinger™ Ablation Catheter and TempLink™ Extension Cable - P000020 [ARCHIVED] Ablation Catheter 11/29/00
PATHWAY™ Her 2 (Clone CB11) - P990081 [ARCHIVED] Breast Cancer Test 11/28/00
Roche Elecsys Total Prostate-Specific Antigen (PSA) Assay on the 1010 and 2010 - p990056 (Revised 2/28/2001) [ARCHIVED] PSA Test 11/22/00
Optical Biopsy™ System [ARCHIVED] Colonoscopy Device 11/14/00
Cordis Checkmate™ System - P990036 [ARCHIVED] Angioplasty Device 11/03/00
Novoste™ Beta-Cath™ System - P000018 [ARCHIVED] Angioplasty Device 11/03/00
Photon™ DR Implantable Cardioverter Defibrillator [ARCHIVED] Defibrillator 10/27/00
Nucleus 24 Auditory Brainstem Implant System - P000015 [ARCHIVED] Hearing Implant 10/20/00
BeStent™ 2 with Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Delivery Systems - P000022 [ARCHIVED] Stent 10/16/00
ATS Open Pivot® Bileaflet Heart Valve [ARCHIVED] Heart Valve 10/13/00
OssaTron - P990086 [ARCHIVED] Shock Wave Therapy 10/12/00
BiodivYsio™AS PC (phosphorylcholine) Coated Stent Delivery System - P000011 [ARCHIVED] Stent 09/29/00
Phylax AV Implantable Cardioverter Defibrillator System with Programmer Software - P000009 [ARCHIVED] Defibrillator 09/29/00
Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators - P000014 [ARCHIVED] Hepatitis Test 09/29/00
TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System [ARCHIVED] Embolizing Device 09/25/00
DTU-One Ultrasound Scanner - P980010 [ARCHIVED] Bone Ultrasound 09/19/00
Bayer Immuno 1™ Complexed Prostate-Specific Antigen (PSA) Assay- P990055 [ARCHIVED] PSA Test 09/08/00
Medstone STS™ Lithotripter - P970042 [ARCHIVED] Shock Wave Therapy 09/05/00
Vibrant Soundbridge - P990052 [ARCHIVED] Hearing Implant 08/31/00
Horizon 55 EW and Horizon 55 EW Westint Contact Lenses - P990072 [ARCHIVED] Contact Lens 08/22/00
QUS-2 Calcaneal Ultrasonometer - P990039 [ARCHIVED] Bone Ultrasound 08/08/00
Medtronic® IsoMed® Constant Flow Infusion System [ARCHIVED] Infusion Pump 07/21/00
Mentor Alpha I Inflatable Penile Prosthesis - P000006 [ARCHIVED] Penile Implant 07/14/00
Mosaic Porcine Bioprosthesis, Model 305 (Aortic) and Model 310 (Mitral) - P990064 [ARCHIVED] Heart Valve 07/14/00
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens - P990018 [ARCHIVED] Contact Lens 07/11/00
Diomed 630 PDT Laser Model T2USA - P990021 [ARCHIVED] Laser 06/30/00
Hyperion™ LTK System - P990078 [ARCHIVED] Laser 06/30/00
Vascular Solutions Duett™ Sealing Device [ARCHIVED] Vascular Sealant 06/22/00
NAVI-STAR® Diagnostic/Ablation Deflectable Tip Catheter - P990025 [ARCHIVED] Ablation Catheter 06/15/00
Medtronic Model 7250 Jewel® AF Implantable Cardioverter Defibrillator System - P980050 [ARCHIVED] Defibrillator 06/14/00
CoStasis/DynaStat Surgical Hemostat - P990030 [ARCHIVED] Vascular Sealant 06/13/00
Stockert 70 RF Generator - P990071 [ARCHIVED] Ablation Device 05/31/00
FocalSeal-Synthetic Absorbable Sealant [ARCHIVED] Lung Sealants 05/26/00
OxiFirst Fetal Oxygen Saturation Monitoring System [ARCHIVED] Fetal Oxygen Monitor 05/12/00

Page Last Updated: 09/05/2013
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