Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TRIVASCULAR, INC OVATION/OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL/TENDRIL ST & OPTISENSE FAMILIES OF LEADS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE VASCULAR CLOSURE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM ICD'S PHOTON MICRO, EPIC, EPIC +, ATLAS, ATLAS + (ICDS)

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR (VAD) ASSIST DEVICE SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)

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

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE Q/PROMOTE QUADRA/UNIFY QUADRA/QUARTET CRT-DS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·ASCENDRA + DELIVERY SYSTEM

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·SOFT ACRYLIC MULTIFOCAL ARRAY 2 (MODELS AA40E AND AA50) AND REZOOM (MODEL NXG1) INTRAOCULAR LENSES

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·QUICK-CLOSE VASCULAR SUTURING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·CARELINK PERSONAL SOFTWARE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VOYAGER OTW CORONARY DILATATION CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·SUTURE MEDIATED CLOSURE SYSTEMS & ASSOCIATED ACCESSORIES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETERS