Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC. GEM DR MODEL 7271 D

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·Mobi-C Cervical Disc Prosthesis

Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

FDA Pre-Market Approval

FDA Class 3 ·Ascension MCP

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·Total Artificial Heart

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·AXSYM AFP

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·INTACS PRESCRIPTION INSERTS

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Prosthesis, Hip, Semi-Constrained, Ceramic-On-Metal Articulation

FDA Pre-Market Approval

FDA Class 3 ·PINNACLE COMPLETE ACETABULAR HIP SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CP900 SERIES SOUND PROCESSORS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX Ceramic Total Hip System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION