Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent with Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE WIRE)

Electrosurgical, Radio Frequency, Refractive Correction

FDA Pre-Market Approval

FDA Class 3 ·VIEWPOINT CK SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·BIOSENSE WEBSTER NAVISTAR/ CELSIUS THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY TINED LEADS, MODELS 3889 AND 3093

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Spiration Valve System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 Ultra Transcatheter Heart Valve System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION INTRAOCULAR LENSES (IOLS), MODELS ZXT150, ZXT225,ZXT300, AND ZT375

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·prodisc L Total Disc Replacement

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL BIOCOR AND BIOCOR SUPRA VALVES

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·MAXUM SYSTEM

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cardiva VASCADE Family

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM ANEURYSM STENT GRAFT