Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·FORTIFY FAMILY OF ICDS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·DEFLUX INJECTABLE GEL

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY (COMFILCON A) SOFT CONTACT LENSES

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·SMART NITINOL STENT SYSTEM AND SMART CONTROL NITINOL STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·INTEGRITY RX CORONARY STENT SYSTEM,INTEGRITY OTW CORONARY STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX/VENTAK MINI FAMILIES OF ICDS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA IMPLANTABLE NEUROSTIMULATORS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·ARTEGRAFT COLLAGEN VASCULAR GRAFT

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT HEART VALVE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·VITAGEL SURGICAL HEMOSTAT (RT3)

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM REAGENT PACK CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM AUSAB

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·COAPTITE INJECTABLE IMPLANT