Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD ENLITE SENSOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Exten

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·SmartAblate Irrigation Tubing Set

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien XT Transcatheter Heart Valve

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX CONTOUR II/MD TIERED THERAPY IMPLANTABLE DEFIBRILLATOR

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·SOLESTA INJECTABLE GEL

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Microny family of Pacemakers

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprothesis

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·Guardian Link (3) Transmitter (MiniMed 670G System)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN SALINE-FILLED BREAST IMPLANTS

Lens, Intraocular, Toric Optics

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM VOLUMA XC

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PORCINE STENTLESS BIOPROSTHETIC VALVES

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·COLLAGRAFT(TM) BONE GRAFT SUBSTITUTE