Device Dossier

Entrant VR ICD Model CDVRA300Q - Defibrillator, implantable, automatic

Device Dossier for Entrant VR ICD Model CDVRA300Q - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor…

Intended purpose

Intended for use with compatible leads to detect and treat life threatening ventricular arrythmias by providing ventricular antitachycardia pacing, and ventricular cardioversion/defibrillation. In addition, these devices can detect and treat chronic symptomatic bradyarrhythmia by providing sensing and pacing in the right ventricle, and various atrioventricular conduction abnormalities by providing sensing and pacing in the right ventricle and/or the right atrium.

Functional description

The device is a single chamber implantable cardioverter defibrillator (ICD) monitors and regulates a patient's heart rate and provides treatment of ventricular arrhythmias. The device is MR conditional.

TGA Public Summary