Device Dossier

IsoFlex Lead Model 1948 - Lead, pacemaker, implantable, endocardial

Device Dossier for IsoFlex Lead Model 1948 - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor…

Intended purpose

IsoFlex? Optim? leads are designed for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Model 1944T) or ventricle (Model 1948T).

Functional description

IsoFlex leads are bipolar, steroid-eluting, passive-fixation implantable pacing leads with Optim insulation. IsoFlex Model 1948T leads can be placed in either the right atrium or the right ventricle.

TGA Public Summary