Device Category Dossier

Lead, defibrillator/pacemaker, implantable

Device Category Dossier for Lead, defibrillator/pacemaker, implantable. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Pacemaker leads are designed for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle, intended for use with VDD pacemakers or other cardiac implantable electronic devices. These leads are placed in the atrium or ventricle to monitor and regulate heart rate through delivery of pacing, cardioversion, and defibrillation therapies for treatment of bradyarrhythmias and life-threatening tachyarrhythmias.