Device Dossier

Optisure IS-1/DF-1, Active Fixation, Dual Coil Leads models LDA220 & LDA230 - Lead, defibrillator/pacemaker, implantable

Device Dossier for Optisure IS-1/DF-1, Active Fixation, Dual Coil Leads models LDA220 & LDA230 - Lead, defibrillator/pacemaker, implantable (Lead,…

Intended purpose

For use with compatible pulse generators to provide pacing, sensing and deliver cardioversion / defibrillation therapy to the heart.

Functional description

For attachment to an implantable cardioverter defibrillator (ICD) with IS-1/DF-1 device header configuration. The leads have two defibrillation electrodes on in the distal portion to provide true bipolar rate sensing, pacing and delivery of cardioversion/defibrillation shocks.

TGA Public Summary