Device Dossier
Fortify Assura DR ICD Model CD2359-40C - Defibrillator, implantable, automatic, dual-chamber
Device Dossier for Fortify Assura DR ICD Model CD2359-40C - Defibrillator, implantable, automatic, dual-chamber (Defibrillator, implantable, automatic,…
- GMDN category: Defibrillator, implantable, automatic, dual-chamber
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 DR CD2359-40C is a dual 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.