Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE BIOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PORCINE AORTIC BIOPROTHESIS, CARPENTIER-EDWARDS PORCINE MITRAL BIOPROTHESIS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC AND AMVISC PLUS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS CRIMPER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER AND CRT-P DEVICES

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

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS CATHETER AND NAVI-STAR DS CATHETER

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC BIOPROSTHESIS MODELS 305 AND 310

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM