Device Dossier
Gallant VR ICD Model CDVRA500T - Defibrillator, implantable, automatic
Device Dossier for Gallant VR ICD Model CDVRA500T - Defibrillator, implantable, automatic (Defibrillator, implantable, automatic, Class III, sponsor…
- GMDN category: Defibrillator, implantable, automatic
Intended purpose
For use with compatible leads to detect and treat life threatening ventricular arrhythmias 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 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.