Australia TGA ARTG recordEndurity PM2160 - 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 PM2160 - Dual-chamber pacemaker, rate-responsive
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- December 14, 2022
- Effective Date
- December 14, 2022
- Country
- United States of America
- Address
- 15900 Valley View Court, Sylmar, California, 91342
The Endurity PM2160 pulse generator 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 a combination of these symptoms. It monitors and regulates a patient's heart rate by providing bradycardia therapy and dual-chamber pacing. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF.
Access comprehensive regulatory information for Endurity PM2160 - 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.