Device Dossier

Advisa SR MRI SureScan Model A3SR01 - Single-chamber pacemaker, rate-responsive

Device Dossier for Advisa SR MRI SureScan Model A3SR01 - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, Class III,…

Intended purpose

The Advisa SR MRI SureScan system is indicated to restore physiologic heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The device is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity.

Functional description

The Medtronic Advisa SR MRI SureScan Model A3SR01 single chamber implantable pacemaker is a multiprogrammable cardiac device that monitors and regulates the patient’s heart rate by providing single chamber rate-responsive bradycardia pacing therapies.

TGA Public Summary