Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin (ISR)

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORTS KITS/BULK/REFILLS KITS/BULKS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE/CAPSURE MODEL/PRODIGY/SERVICE KIT-PACEMAKER REPAIR KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SIDE CATHETER ACCESS PORT KITS/BULK/REFILLS KITS/BULK

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·WRENCH & REPLACEMENT SETSCREW ACCESSORY KIT & ACCESSORY KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·INJEX ANCHOR KITS AND VECTRIS SURESCAN MRI LEAD KITS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED PUMP AND INFUSION SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·Titan Inflatable Penile Prosthesis (IPP)

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM