Device Dossier
AUTOGEN ICD VR – Model D044 - Defibrillator, implantable, automatic
Device Dossier for AUTOGEN ICD VR – Model D044 - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor Boston…
- GMDN category: Defibrillator, implantable, automatic
Intended purpose
Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Functional description
AUTOGEN VR-single-chamber ICD provides combining ventricular tachyarrhythmia therapy with ventricular pacing and sensing. Cardioversion/defibrillation therapies include a range of low- and high-energy shocks using a biphasic waveform and choice of multiple shock vectors.