Device Dossier

RESONATE EL ICD VR Model D432 - Defibrillator, implantable, automatic

Device Dossier for RESONATE EL ICD VR Model D432 - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor…

Intended purpose

This device is intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

Functional description

RESONATE EL single-chamber ICD combines ventricular tachyarrhythmia therapy with ventricular pacing and sensing. Cardioversion or defibrillation therapies include a range of low- and high- energy shocks using a biphasic waveform; and a choice of multiple shock vectors.

TGA Public Summary