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Allure RF PM3222 - Biventricular pacemaker

Access comprehensive regulatory information for Allure RF PM3222 - Biventricular pacemaker 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.

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Class III
Class III
Allure RF PM3222 - Biventricular pacemaker
Australia TGA ARTG Registered Device
Good Name: Abbott Medical Australia Pty Ltd - Allure RF PM3222 - Biventricular pacemaker
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Intended Purpose

The Allure PM3222 is intended for patients who would benefit from resynchronization of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. 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.

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
Manufacturer
Country
United States of America
Address
15900 Valley View Court, Sylmar, California, 91342