Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CARDIAC ABLATION CATHETERS

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Neuroform Atlas® Stent System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise, Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus Deep Brain Stimulation (DBS) Systems

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Bioprosthesis

Analyzer, Diagnostic, Fiber Optic (Colon)

FDA Pre-Market Approval

FDA Class 3 ·WAVSTAT (TM) OPTICAL BIOPSY SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA Pre-Market Approval

FDA Class 3 ·DAKO EGFR PHARMDX KIT

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valves

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Hancock Modified Orifice Valved Conduit

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

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR RMT DS ,EZ STEER NAV DS ,CELSIUS FLTR, CELSIUS DS, & NAVISTAR DS CATHETERS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL AORTIC AND MITRAL BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC/ATLAS/PROMOTE FAMILY OF CRT-DS