Device Dossier

Durata Defibrillation Lead Model 7121Q - Lead, defibrillator, implantable

Device Dossier for Durata Defibrillation Lead Model 7121Q - Lead, defibrillator, implantable (Lead, defibrillator, implantable, Class III, sponsor Abbott…

Intended purpose

For use with a compatible pulse generator to provide long‑term cardiac sensing, pacing, and delivery of cardioversion/defibrillation therapy to treat life‑threatening ventricular arrhythmias in the right ventricle.

Functional description

The lead is a true bipolar, steroid‑eluting, active fixation lead with two defibrillation electrodes. The lead is designed for long‑term attachment to an ICD or CRT‑D. The lead is designed for implantation with the distal tip positioned in the right ventricle and provide rate‑sensing, pacing, and delivery of cardioversion/defibrillation shocks.

TGA Public Summary