Device Dossier

Fortify Assura DR CD2359-40QC - Defibrillator, implantable, automatic

Device Dossier for Fortify Assura DR CD2359-40QC - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, AIMD, sponsor Abbott…

Intended purpose

The Fortify Assura DR CD2359-40QC is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF. This device is MRI conditional.

Functional description

The Fortify Assura DR CD2359-40QC is a dual chamber implantable cardioverter defibrillator (ICD) with RF telemetry and it monitors and regulates a patient's heart rate by providing ventricular tachyarrhythmia therapy. It features a DF4 device header and Parylene coating.

TGA Public Summary