Device Dossier

CapSure Fix Novus MRI SureScan Model 5076 - Lead, defibrillator/pacemaker, implantable

Device Dossier for CapSure Fix Novus MRI SureScan Model 5076 - Lead, defibrillator/pacemaker, implantable (Lead, defibrillator/pacemaker, implantable,…

Intended purpose

The Model 5076 lead is intended for use in the right atrium or right ventricle to monitor and regulate the patient’s heart rate by delivery of pacing therapies for the treatment of bradyarrhythmias

Functional description

The Medtronic CapSureFix Novus MRI SureScan Model 5076 steroid eluting, bipolar, implantable, screw-in, ventricular/atrial,transvenous lead is designed for pacing and sensing applications in either the atrium or ventricle. The lead has been tested for use in the Magnetic Resonance Imaging (MRI) environment.

TGA Public Summary