Device Dossier

DYNAGEN ICD VR – Model D150 - Defibrillator, implantable, automatic

Device Dossier for DYNAGEN ICD VR – Model D150 - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor Boston…

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

DYNAGEN 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.

TGA Public Summary