Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX ICD'S USING MODEL 3307, V2.1A PROGRAMMER SOFTWARE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Navistar/Celsius DS Diagnostic/Ablation Deflectable 8MM Tip Catheter

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·NOVAFLEX+ DELIVERY SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate II Left Ventricular Assist System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G Insulin Pump

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier - Edwards Perimount Magna East Pericardial Aortic Bioprosthesis with ThermaFix tissue process

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ONE-PIECE SOFT ACRYLIC INTRAOCULAR (IOL) MODEL ZCB00 & TECNIS MULTIFOCAL ONE-PIECE IOL MODEL ZMB00

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve

Absorbable Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS CL Foldable Silicone Intraocular Lens

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G Insulin Pump

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX2 Endovascular AAA System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SofPort Posterior Chamber Intraocular Lenses

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis and Hancock II Bioprosthesis