Australia TGA ARTG record

Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive

Australia TGA ARTG Registered Device · Abbott Medical Australia Pty Ltd · St Jude Medical Cardiac Rhythm Management Division · Class III · Started December 14, 2022

Good Name: Abbott Medical Australia Pty Ltd - Endurity MRI PM2172 - Dual-chamber pacemaker, rate-responsive

Device classification

Risk Class: Class III
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 14, 2022
Effective Date: December 14, 2022

Sponsor

Name: Abbott Medical Australia Pty Ltd

Manufacturer

Name: St Jude Medical Cardiac Rhythm Management Division
Country: United States of America
Address: 15900 Valley View Court, Sylmar, California, 91342

Intended purpose

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.

About this record

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.