Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT Transcatheter Heart Valve

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT RSR Theon/Magna/Plus Pericardial Aortic Bioprosthesis with ThermalFix tissue process,

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Infinity™ Deep Brain Stimulation (DBS) IPG

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL Vascular Closure Devices

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN LPS-FLEX MOBILE AND LPS BEARING KNEES

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MECHANICAL HEART VALVES

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra OPUS Silicone Gel Breast Implants

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL RT3 SUTGICAL HEMOSTAT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, implantable, dual-chamber

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Permanent, Implantable

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

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·FLEXABILITY ABLATION CATHETER (BI-DIRECTIONAL) , FLEXABILITY ABLATION CATHETER (UNI-DIRECTIONAL)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Cardiac CryoAblation Catheters

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·TITAN INFLATABLE PENILE PROSTHESIS

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone