Australia TGA ARTG recordInfinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor
Australia TGA ARTG Registered Device · Abbott Medical Australia Pty Ltd · St Jude Medical · Class III · Started October 06, 2022
Good Name: Abbott Medical Australia Pty Ltd - Infinity 7 IPG, Header M, Model 6663 - Brain electrical stimulation system, antitremor
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 06, 2022
- Effective Date
- October 06, 2022
- Name
- St Jude Medical
- Country
- United States of America
- Address
- 6901 Preston Road, Plano, Texas, 75024
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 Parkinson’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.
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.