Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SPINAL CORD STIMULATION SYSTEMS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED INFUSION SYSTEM

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE MINIATURE TELESCOPE (IMT)

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

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

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·LIVEWIRE TC CARDIAC ABLATION SYSTEM

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INTERSTIM THERAPY FOR URINARY CONTROL

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·EVOQUE Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Certitude Delivery System, Edwards Certitude Introducer Sheath Set, Edwards Commander Delivery System, Edwards C

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Implant System, PASCAL Precision Guide Sheath

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated PTA Balloon Catheter

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·HER OPTION CRYOABLATION THERAPY SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED PROGRAMMABLE INFUSION PUMPS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·TENEO 317 Model 2

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI 4965/4968

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE AND CAPSURE NOVUS FAMILIES OF LEADS/ACCESSORIES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 700/600, SIGMA AND 350 SERIES FAMILIES OF PULSE GENERATORS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·iSert Preloaded IOL Models, iSymm, Clarisert IOL Models