Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL LEAD SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700, 2700TFX 2800TFX

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minerva Endometrial Ablation System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 Transcatheter Heart Valve

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Saline-Filled Breast Implants

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/IDENTITY/INTEGRITY/VICTORY/ZEPHYR FAMILY OF PACEMAKERS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS TAQMAN HBV TEST

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENTGRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR SYSTEM (SCS)

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·CONTIGEN BARD COLLAGEN IMPLANT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EPIC,EPIC+,ATLAS+, ATLAS, PHOTON MICRO,PHOTON, ICD'S