ARTG 474045Single Chamber Temporary External Pacemaker, Model 53401 - Pacemaker, cardiac, external, invasive
ARTG ID: 474045 · Medtronic Australasia Pty Ltd · Medtronic Inc · Class III · Started December 19, 2024
Good Name: Medtronic Australasia Pty Ltd - Single Chamber Temporary External Pacemaker, Model 53401 - Pacemaker, cardiac, external, invasive
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 474045
- Start Date
- December 19, 2024
- Effective Date
- December 19, 2024
- Name
- Medtronic Inc
- Country
- United States of America
- Address
- 710 Medtronic Parkway, Minneapolis, MN, 55432
The TEP is an external device intended for short-term use, typically in a hospital environment, to monitor and regulate the patient’s heart rate. The TEP is used for atrial and/or ventricular sensing and pacing in conjunction with a cardiac pacing lead system. The TEP senses intrinsic electrical activity through lead electrodes, analyzes heart rhythms based on programmed detection parameters, and delivers pacing pulses to treat bradyarrhythmias. A secondary function of the TEP is to provide high-rate burst pacing therapy indicated for atrial use only.
Access comprehensive regulatory information for Single Chamber Temporary External Pacemaker, Model 53401 - Pacemaker, cardiac, external, invasive in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 474045 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Medtronic Inc in United States of America. The device registration started on December 19, 2024.
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.