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

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW-L BP LEFT VENTRICULAR PACING LEAD

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDEARDS DURAFLEX LOW PRESSURE PROCINE MITRAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINBE MITRAL BIOPROSTHESIS

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MONORAIL & OTW CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX SONIC BALLOON EXPANDABLE STENT OTW DELIVERY SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL KR10UV,THREE PIECE IOL/W PMMA HAPTICS

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD,LEFT VENTICULAR PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·OpticSense, Tendril STS, SDX, ST Low Voltage Active

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, LEFT VENTRICULAR PACING LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 MONORAIL AND OTW CORONARY STENT SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORTACATH/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD , LEAD VENTRICULAR PACING LEAD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril ST and Tendril STS Low Voltage Leads

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS