Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Protege GPS Self-Expanding Peripheral Stent System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·OPTUNE (FORMERLY THE NOVOTTF-100A SYSTEM)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM & GEM II VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III DR 7275, GEM III VR 7231, GEM DR 7271

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC. GEM MODEL 7227CX, GEM III DR MODEL 7275, GEM III VR MODEL 7231 AND GEM III AT MODEL 7276

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·BRIO NEUROSTIMULATION SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM DR

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7271 GEM DR, MODEL 7273 GEM II DR, MODEL 7275 GEM III DR ICDS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM II VR ICD,MARQUIS VR ICD,GEM III VR ICD,MAXIMO VR ICD,GEM DR ICD,GEM II DR ICD,MARQUIS DR ICD,GEM III DR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM, GEM II, GEM III, INTRINSIC, MARQUIS, MAXIMO, MAXIMO II, ONYX, PROTECTA, SECURA, VIRTUOSO, VITUOSO II, ENTRUST