Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive
Access comprehensive regulatory information for Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Abbott Medical Australia Pty Ltd, manufactured by St Jude Medical Cardiac Rhythm Management Division in United States of America. The device registration started on December 14, 2022.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The Endurity MRI PM2172 is intended to be implanted when a patient has one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. It monitors and regulates a patient's heart rate by providing bradycardia therapy and dual-chamber pacing. The implantation of Endurity MRI PM2172 is also intended for patients exhibiting: sick sinus syndrome, chronic, symptomatic second-degree and third-degree AV block, recurrent Adam-Stokes syndrome, symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.