Device Dossier
Gallant HF CRT-D Model CDHFA500T - Biventricular pacemaker/defibrillator
Device Dossier for Gallant HF CRT-D Model CDHFA500T - Biventricular pacemaker/defibrillator (Biventricular pacemaker/defibrillator, Class III, sponsor…
- GMDN category: Biventricular pacemaker/defibrillator
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. CRT‑D devices sense cardiac activity and provide pacing to resynchronize the right and left ventricles.
Functional description
The device is a cardiac resynchronisation therapy defibrillator (CRT-D) monitors and regulates a patient's heart rate and provides treatment of ventricular arrhythmias. As a CRT-D device, it also senses cardiac activity and provides pacing to resynchronize the right and left ventricles. The device is MR conditional.