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1x4 Pocket Adapter Kit Model 64001 - Neural-tissue electrical stimulation lead adaptor - ARTG 483626

Access comprehensive regulatory information for 1x4 Pocket Adapter Kit Model 64001 - Neural-tissue electrical stimulation lead adaptor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 483626 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Medtronic Inc in United States of America. The device registration started on March 21, 2025.

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
ARTG 483626
Class III
1x4 Pocket Adapter Kit Model 64001 - Neural-tissue electrical stimulation lead adaptor
ARTG ID: 483626
Good Name: Medtronic Australasia Pty Ltd - 1x4 Pocket Adapter Kit Model 64001 - Neural-tissue electrical stimulation lead adaptor
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Intended Purpose

To conduct stimulation between the INS and an extension as part of a DBS system. Adaptors are used for revision surgeries when the new INS is not electromechanically compatible with the existing extensions.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
483626
Start Date
March 21, 2025
Effective Date
March 21, 2025
Manufacturer
Country
United States of America
Address
710 Medtronic Parkway, Minneapolis, MN, 55432