Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II AND BLAZER PRIME HTD CARDIAC ABLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO/INSYNC SENTRY/INSYNC MAXIMO

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CMDS)

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® CR2 defibrillator

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CARELINK ENCORE 29901 PROGRAMMER

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix 035

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE XPEDITION & ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P,Solar Bipolar CRT-P,

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM SFA and PPA

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT SYSTEM W/ the Captivia Delivery System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Rheolythic Thrombectomy Catheter

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP