Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE II/FINELINE II STEROX PACING LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOCURVE SOFT CONTACT LENSES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/800/900 & ENPULSE FAMILIES OF PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX5000 PROGRAMMER

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALL STENT ILIAC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·HYDROVIEW IOL BLANK MATERIAL

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spinal Cord Stimulation (SCS)

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG Systems

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System