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

Femtosecond Laser System For Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VISUMAX 800

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·MEL 80 Excimer Laser

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL IDENTITY, VERITY, INTEGRITY, VICTORY & AFFINITY PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI family of Pacemakers,

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Ideal Implant Structured Breast implant