Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN PERFORMA MODEL 4298 LEAD

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK & RENEWAL TR FAMILY, CRT-P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL ELUTING CORONARY STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX, CAPSUREFIX NOVUS, SUREFIX

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VITALITY & VITALITY AVT FAMILY

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE / PROMOTE+ CRT-D

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CORDIS CYPHER SIROLIMUS-ELUTING CORONARY STENT

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GEL

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia, Claria MRI CRT-D, Amplia, Claria and Compia MRI Quad CRT-D, Brava Quad CRT-D, Brava, Consulta and Protecta CRT-D

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System SNS Urinary Neurostimulator

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO® RX Self-expanding Peripheral Stent

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Bard E-Luminexx and LifeStar Vascular Stent

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RHA 2, RHA 3, RHA 4 dermal fillers