Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MODEL VSA02/VSC02 V9.0 PROGRAMMING SOFTWARE FOR THE DIVA, DEMA, AND SELECTION AFM MODEL 902 PULSE GENERATORS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·DEMA, DIVA AND AFM PULSE GENERATORS

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·NIT-OCCLUD PDA

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·PMA NIT-OCCLUD PDA

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 5076 LEAD

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL Cochlear Implant System

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·COMBI 40+ COCHLEAR IMPLANT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DIVA PACING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·350 SERIES/ADAPTA/ADVISA/ENRHYTHM/RELIA/SENSIA/SIGMA/VERSA

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD