Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® 35 Monitor/Defibrillator

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SofLens 38 (polymacon) Visibility Tinted Contact Lens

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER/MICRO-DRIVER AND INTEGRITY CORONARY STENT SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT STENT GRAFT SYSTEMS

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC HIP SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Sapien 3 Transcatheter Heart Valve and Accessories

Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation

FDA Pre-Market Approval

FDA Class 3 ·Sphere-9™ Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA,ENERGEN AND PUNCTUA ICDS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR GLUCOSE SENSOR

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Stimulator, Hypoglossal Nerve, Implanted, Apnea

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, INCEPTA, ENERGEN, PUNCTUA

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ADVANTIO, INGENIO, VITALIO, AND FORMIO

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, and Intellis Spinal Cord Stimulation Systems

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Hip System