Replacement Heart-Valve

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS MR & OTW CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY RX & OTW CORONARY STENT SYSTEMS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Tendril and Optisense f Low Voltage Leads

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Pre-Market Approval

FDA Class 3 ·EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 0.035 OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex™ 0.035” OTW Drug-coated Angioplasty Balloon

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·Integrity Coronary Stent System Rx and OTW

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 MONORAIL AND OTW CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·LIBERTE MR & OTW CORONARY STENT SYSTEM