Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System or HeartWare® System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY™ Everolimus-Eluting Platinum Chromium Coronary Stent Systems

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) and Prom

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE XPEDITION,XIENCE XPEDITION SV AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist Device System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE MR CORONARY STENT SYSTEM & TAXUS LIBERTE OTW CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED BVS5000 BI-VENTRICULAR SUPPORT SYSTEM AND AB5000 CIRCULATORY SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (HM3 LVAS)