Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 WITH DISCRETE TECHNOLOGY (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL)

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY AND MIDIFIED ORIFICE VALVED CONDUIT MODEL 105

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE OTW/PRECISE RX & PRECISE PRO RX NITINOL STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MO & OTW

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY & MODIFIED ORIFICE VALVED CONDUIT MODEL 150

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, 4194 AND LEFT VENTRICULAR PACING LEAD, 4193

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK I LOW POROSITY AND MODIFIED ORIFICE VALVED CONDUIT MODEL 150

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL & OTW)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW)

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·Wolverine Coronary Cutting Balloon Monorail (MR) and Over-the-Wire (OTW)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PRECISE OTW 5.5 FR AND 6.0 FR NITINOL STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM