Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META III MODEL 1206,1206E,1206M PACING SYSTEMS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ZYDERM ZYPLAST COLLAGEN IMPLANT COSMODERM COSMOPLAST HUMAN COLLAGEN IMPLANT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PACEMAKER AND CRT-P DEVICES

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL AND TRANSAPICAL ACCESSORIES

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYSHAPE BREAST IMPLANTS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·TENDRIL/TENDRIL ST/OPTISENSE LEADS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Over The Wire Zotarolimus-Eluting Coronary Stent System, Resolute Onyx Frontier Rapid Exchange Zotarolimus

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II/ANTHEM FAMILY OF CRT-PS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ellipse, Fortify, Fortify Assura and Quadra Assura MP ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, and Juvéderm Ultra Plus XC

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE ONYX ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 283 PULSE GENERATOR & MODEL 370 PROGRAMMER

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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