Device Dossier

Durata Lead model 7121Q - Lead, defibrillator/pacemaker, implantable

Device Dossier for Durata Lead model 7121Q - Lead, defibrillator/pacemaker, implantable (Lead, defibrillator/pacemaker, implantable, Class III, sponsor…

Intended purpose

The Durata model 7121Q transvenous lead is indicated for use with compatible pulse generators. They provide pacing and sensing and delvier cardioversion/defibrillation therapy to the heart.

Functional description

The Durata model 7121Q transvenous tachyarrhythmia lead is a true bipolar,steroid-eluting,active fixation implantable lead with two defibrillation electrodes.The lead is designed for implantation with the distal tip positioned in the right ventricle.The lead is packaged with a stylet and suture sleeve in place,1 extra suture sleeve,vein pick,2 clip-on tools,lead cap and stylets of varying firmness.

TGA Public Summary