Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Azure Astra App and Azure Astra DR/SR/XT MRI SureScan IPGs

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·350 SERIES/ADAPTA/AT500/ENPULSE/ENRHYTHM/KAPPA 700/800/900/RELIA/SENSIA/SIGMA/VERSA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENRHYTHM (IPG)

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT FIDELIS & QUATTRO

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CARDIAC RESYNCHRONIZATION THERAPY PACING (CRT-P) & INSYNC III CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/VERSA/SENSIA IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG; Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG; Astra S DR MRI IPG, Astra S SR MRI IPG,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA IPGS, SIGMA IPGS, ENPULSE IPGS, ENRHYTHM IPGS, AT500 PACING SYSTEM, ADAPTA/SENSIA/VERSA IPGS AND RELIA IPG

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

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

FDA Pre-Market Approval

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

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software