Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (VENOUS) ENDOPROSTHESIS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (ILIAC) ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT TIPS ENDOPROSTHESIS

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE.

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien 3 Transcatheter Heart Valve

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·KONECT RESILIA Aortic Valved Conduit (AVC)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS 2 CORNARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXE-ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROTHESIS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS CORONARY STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Qualcrimp crimping accessory (Packaged with the Commander Delivery System)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 CORONARY STENT SYSTEM