Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX LEAD/CAPSUREFIX LEAD/CAPSUREFIX NOVUS/PIROUET

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 5.5 with SmartAssist

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella Ventricular Support Systems

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G Insulin Pump

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P, VIVA CRT-P

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED FAMILY OF IMPLANTABLE FUSION PUMPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P & VIVA CRT-P

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Lead

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Mosaic Bioprosthesis and Hancock II Bioprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400 DR IPG AND KAPPA 400 SR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/SENSIA/VERSA/RELIA

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMER SOFTWARE (1503.U) FOR THE ICS 3000/RENAMIC PROGRAMMERS

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED IMPLANTABLE INFUSION SYSTEM

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SOLETRA IMPLANTABLE NEUROSTIMULATOR/KINETRA IMPLANTABLE NEUROSTIMULATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II BIOPROSTHETIC HEART VALVE