Device Dossier

Durata Defibrillation Lead Model 7122Q - Lead, defibrillator, implantable

Device Dossier for Durata Defibrillation Lead Model 7122Q - 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 one defibrillation electrode. 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. The 58cm and 65cm lead lengths are MR conditional.

TGA Public Summary