Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEL BREAST IMPLANT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

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

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACUITY SPIRAL LEAD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEM

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRESTIGE(R) LP CERVICAL DISC

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

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

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·RIATA ST OPTIM AND RIATA STS OPTIM LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX SYSTEM (NIRXCELL STENT SYSTEM)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL EXACT SPINE SEALANT

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·CONSERVE PLUS HIP RESURFACING SYSTEM NEW ENROLLMENT STUDY (NES) PROTOCOL

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·NUVASIVE'S PCM CERVICAL DISC

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CARTOID WALLSTENT MONORAIL ENDOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED