Device Dossier
Aveir VR Leadless Pacemaker Model LSP112V - Intracardiac pacemaker
Device Dossier for Aveir VR Leadless Pacemaker Model LSP112V - Intracardiac pacemaker (Intracardiac pacemaker, Class III, sponsor Abbott Medical). ARTG…
- GMDN category: Intracardiac pacemaker
Intended purpose
The Aveir VR Leadless Pacemaker (LP) Model LSP112V is designed to provide bradycardia pacing as a pulse generator with a built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.
Functional description
The Aveir VR Leadless Pacemaker (LP) provides bradycardia pacing as a pulse generator for implantation in the right ventricle. As a leadless pacemaker device, it does not need a pacing lead. The Aveir VR LP has a docking button for delivery to or retrieval from the right ventricle of the heart by using the Aveir Delivery Catheter and Aveir Introducer (to deliver) or Aveir Retrieval Catheter (to retrieve).