Device Dossier

Fortify Assura VR ICD Model CD1359-40QC - Defibrillator, implantable, automatic

Device Dossier for Fortify Assura VR ICD Model CD1359-40QC - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III,…

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 Fortify Assura VR ICD Model CD1359-40QC is a single chamber implantable cardioverter defibrillator (ICD) with RF telemetry and it monitors and regulates a patient's heart rate. It features a DF4 device header and Parylene coating.

TGA Public Summary