Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·Heartware Ventricular Assist System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·IPULSE CIRCULATORY SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LVAS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC{R} CAPSURE{TM} MODEL 5052/5525

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·Berlin Heart EXCOR Pediatric Ventricular Assist Device

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC HEARTMATE XVE LVAS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·CentriMag Circulatory Support System

Permanent Pacemaker Electrode

FDA Pre-Market Approval

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

Permanent Pacemaker Electrode

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

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

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Model 5071 Lead

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) PACING LEADS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP