Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CLARION MULTI-STRATEGY COCHLEAR IMPLANT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·CCOBAS AMPLIPREP/COBAS TAQMAN HBV TEST V2.0

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·RX HERCULINK ELITE RENAL STENT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE (VAD)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT IIS STENT GRAFT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+FAMILY OF ICDS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES/TECNIS 1-PIECE LENS MODEL ZCB00

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY CARDIAC ABLATION CATHETERS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOLOGIC 1000-SC BONE GROWTH STIMULATOR

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