Medical Devices Approved by FDA in 2000

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