System, Identification, Contact Lens

FDA Pre-Market Approval

FDA Class 3 ·SOFTMARK

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS B-13F (P-10) & B-1H (P-11)

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MODEL 5342 & 5245 PULSE GENERATOR

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS HF SYSTEM

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE

Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation

FDA Pre-Market Approval

FDA Class 3 ·Vivistim® System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·PROTEGO FAMILY OF ICD LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MYCARELINK PATIENT MONITOR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY/HEPACOAT ON RAPTOR STENT SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHER HEART VALVE

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 COCHLEAR IMPLANT SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC RESPORE FAMILY OF IMPLANTABLE NEUROSTIMULATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO DR/VR

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·MAESTRO 3000 CARDIAC ABLATION SYSTEM