Device Dossier

CapSureFix Novus MRI SureScan Model 4076 - Lead, pacemaker, implantable, endocardial

Device Dossier for CapSureFix Novus MRI SureScan Model 4076 - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class…

Intended purpose

The Model 4076 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 4076 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