Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·Biomet® OrthoPak Non-invasive Bone Growth Stimulator System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Celsius, Celsius RMT, EZ Steer Bi-directional non nav

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT (MCH) NON-WOVEN WEB/ENDOAVITENE

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS Vascular Stent

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS Vascular Stent

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART, MODEL 9000TFX

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·AUTIMA/AURORA CARDIAC PACING SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHER HEART VALVE, MODEL 9000TFX

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·GORE Carotid Stent

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM