Device Dossier
Allure RF PM3222 - Biventricular pacemaker
Device Dossier for Allure RF PM3222 - Biventricular pacemaker (Biventricular pacemaker, Class III, sponsor Abbott Medical). ARTG record, intended…
- GMDN category: Biventricular pacemaker
Intended purpose
The Allure PM3222 is intended for patients who would benefit from resynchronization of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. 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.
Functional description
The Allure PM3222 is a CRT-P with RF telemetry, patient notification capability and Corvue congestion monitoring. This device can be programmed with a Merlin Patient Care System and has device header with IS-1 connector for connection of unipolar or bipolar IS-1 leads.