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Quadra Allure MP RF PM3262 - Biventricular pacemaker

Access comprehensive regulatory information for Quadra Allure MP RF PM3262 - 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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TGA ARTG Official Data
Class III
Class III
Quadra Allure MP RF PM3262 - Biventricular pacemaker
Australia TGA ARTG Registered Device
Good Name: Abbott Medical Australia Pty Ltd - Quadra Allure MP RF PM3262 - Biventricular pacemaker
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Intended Purpose

The Quadra Allure MP RF PM3262 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. The implantation of Quadra Allure MP RF PM3262 is also intended for patients who would benefit from resynchronisation of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. Also the Quadra Allure MP RF PM3262 is indicated for patients who exhibit sick sinus syndrome, chronic symptomatic second-degree and third-degree AV block, recurrent Adam-Stokes syndrome and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

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