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

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARD SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Thrombectomy Catheter

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·Seprafilm Adhesion Barrier

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE RING,CARPENTIER-EDWARDS DURAFLEX LOW

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD MONORAIL ILIAC PREMOUNTED STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·DUROMEDICS BILEAFLET HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS) ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA Self Expanding Stent System