Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACCENT DR, ACCENT DR RF, ACCENT SR, ACCENT SR RF PACEMAKERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista One Piece Hydrophobic Acrylic Intraocular Lens

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

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 ·Thermocool Smarttouch SF

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·APPLICATION SOFTWARE MODEL 3307 (VERSION 4.1A)

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL DX AND TENDRIL SDX ENDOCARDIAL PACING LEADS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE/CURRENT FAMILY OF ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX XL DC,SR/ADX VDR/ADX XL DR,DR,SR/VERITY ADX XL VDR/ADX XL DR,DR,DC/ADX XLSR,SR,SC

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/EPIC+ HF/EPIC II HF/EPIC II+HF/ATLAS HF/ATLAS+HF/ATLAS II HF/ATLAS II+HF CRT-DS/QUICKSITE/QUICKFLEX LEADS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

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

FDA Pre-Market Approval

FDA Class 3 ·Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM & PERCLOSE A T 6F SUTURE-MEDIATED CLOSURE SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·PASSIVE PLUS DX STEROID ELUTING, ENDOCARDIAL PACING LEADS