System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·STAAR VISION IMPLANTABLE COLLAMER LENS

Sensor, Electro-Optical (For Cervical Cancer)

FDA Pre-Market Approval

FDA Class 3 ·LUMA CERVICAL IMAGING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META-MV,PACING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCOM SEVEN AND SEVEN PLUS SYSTEM

Lens, Intraocular, Accommodative

FDA Pre-Market Approval

FDA Class 3 ·CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI SPINAL CORD STIMULATOR (SCS) SYSTEM.

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SOFTWARE MODEL 3264 REV A

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODEL 2625, 6625 AND VALVED CONDUIT MODEL 4300

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY FAMILY OF ICDS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT CONTACT LENSES

Drug-Eluting Sinus Stent

FDA Pre-Market Approval

FDA Class 3 ·PROPEL AND PROPEL MINI SINUS IMPLANTS

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Verity 5056, 5156, 5256, 5356, 5456, 5816; Zephyr 5826, 5626; Identity 5286, 5386; Sustain XL PM1134, PM1136, PM2134, PM