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Infinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor

Access comprehensive regulatory information for Infinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor 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 in United States of America. The device registration started on October 06, 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
Infinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor
Australia TGA ARTG Registered Device
Good Name: Abbott Medical Australia Pty Ltd - Infinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor
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Intended Purpose

The neurostimulation system is indicated for unilateral or bilateral stimulation of the thalamus, internal globus pallidus or subthalamic nucleus in patients who are at least 18 years old with levodopa-responsive Parkinsonโ€™s disease; unilateral or bilateral stimulation of the ventral intermediate nucleus of the thalamus for the management of tremor for patients who are at least 18 years old; unilateral or bilateral stimulation of the internal globus pallidus of the subthalamic nucleus for the management of intractable, chronic dystonia, including primary and secondary dystonia for patients who are at least 7 years old.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 06, 2022
Effective Date
October 06, 2022
Manufacturer
Country
United States of America
Address
6901 Preston Road, Plano, Texas, 75024