Device Dossier

INGEVITY MRI pace/sense lead passive fixation preformed Atrial J system - Lead, pacemaker, implantable, endocardial

Device Dossier for INGEVITY MRI pace/sense lead passive fixation preformed Atrial J system - Lead, pacemaker, implantable, endocardial (Lead, pacemaker,…

Intended purpose

Intended for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator

Functional description

Endocardial pace/sense lead—intended for chronic bipolar pacing and sensing in the atrium and/or ventricle. Leads have a IS-1 bipolar to be used in conjunction with a compatible cardiac device. Leads are MR Conditional when connected to Boston Scientific MR Conditional pulse generators. Steroid-eluting—upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode.

TGA Public Summary