Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Application Software for Micra Transcatheter Pacing System MC1VR01

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

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·POCKET ADAPTOR KIT, ITREL 3, SYNERGY & SYNERGY VERSITREL

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN PERFORMA QUADRIPOLAR LEAD

P2psa

FDA Pre-Market Approval

FDA Class 3 ·ACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus/CapSure SP Z/CapSure Z Novus/Vitatron Impulse II Lead

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX NOVUS LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE LEADS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo PRO Delivery Catheter System, EnVeo PRO Loading System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL 3, SYNERGY,RESTORE PRIME & PRIME ADVANCED FAMILY OF IPG/IMPLANTABLE NEUROSTIMULATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PRIZM & VITALITY FAMILIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN OTW MODEL 4193

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/RELIA/SENSIA/VERSA IPGS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·ACTIVA IMPLANTABLE NEUROSTIMULATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC PROTECTA XT/PROTECTA/SECURA/MAXIMO II DR DF4 DEVICES (D314DRM, D334DRM, D204DRM AND D264DRM)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM