Device Dossier

Ellipse VR ICD Model CD1377-36C - Defibrillator, implantable, automatic

Device Dossier for Ellipse VR ICD Model CD1377-36C - 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, the device 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 Ellipse VR ICD Model CD1377-36C is a single chamber implantable cardioverter defibrillator (ICD) with RF telemetry and it monitors and regulates a patient's heart rate. It features an IS-1/DF-1 device header and Parylene coating.

TGA Public Summary