Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS, GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MEMORYGEl BREAST IMPLANTS

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

MODEL 5650 OPTIMATE PERSONAL PROGRAMMER

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·LGW

MAXIMA FILTERED HARDSHELL RESERVOIR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Isoflex Low Voltage Lead

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE, RADIESSE LOW VISCOSITY

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE LOW VISCOSITY, RADIESSE (+)

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Isoflex Low Voltage Leads

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE BIOPROSTHESIS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IsoFlex Low Voltage Passive

Stimulator, Low Electric Field, Tumor Treatment

FDA Pre-Market Approval

FDA Class 3 ·Novocure Ltd.'s Optune

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS; BIOPROSTHESIS-EDWARDS DURAFLEX LOW PRESSURE MITRA

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS WITH EXTENDED SUTURE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE, PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS,CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE