Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Transvene CS/SVC Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, INSYNC, INSYNC III, SYNCRA CRT-P

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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75 BP & 85 BP; COROX OTW-L 75 BP & 85 BP; COROX OTW-S 75 BP & 85 BP

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

FDA Pre-Market Approval

FDA Class 3 ·CRYOABLATION CONSOLE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX TETRA/OTW TETRA CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE AAA ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·CURRENT + DEVICES & CURRENT ACCEL DEVICES

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II/THINLINE II STEROX LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDURANCE EZ ENDOCARDIAL DEFIBRILLATION LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF V-338

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P