Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FLEX AAA ENDOVASCULAR GRAFT

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V Everolimus Eluting Coronary Stent System / XIENCE nano Everolimus Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Claria MRI CRT-D, Amplia, Claria and Compia MRI Quad CRT-D, Brava Quad CRT-D, Brava, Consulta and Protecta CRT-D

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO® RX Self-expanding Peripheral Stent

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Ultra Transcatheter Heart Valve

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Bard E-Luminexx and LifeStar Vascular Stent

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve and SAPIEN 3 Ultra™ Transcatheter Heart Valve.

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Epic Self Expanding Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CardioMEMS HF System

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·FARAPULSE™ Pulsed Field Ablation System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Navitor Transcatheter Aortic Heart Valves

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEMINI(R) THETA MODEL 415A CARDIAC PACER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate Irrigation Pump, nGEN Pump Devices

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Patient Monitor

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·FINELINE II STEROX ENDOCARDIAL PACING LOEADS & FINELINE II STEROX EZ ENDOCARDIAL PACING LEADS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Commander Delivery System; Certitude Delivery System; Certitude Introducer Sheath; Crimper

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

FDA Pre-Market Approval

FDA Class 3 ·EPIC HF/ATLAS+ HF FAMILY OF CRT-DS