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Proclaim 5 Elite IPG, Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable

Access comprehensive regulatory information for Proclaim 5 Elite IPG, Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable 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 05, 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
Proclaim 5 Elite IPG, Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable
Australia TGA ARTG Registered Device
Good Name: Abbott Medical Australia Pty Ltd - Proclaim 5 Elite IPG, Model 3660 - Analgesic spinal cord electrical stimulation system pulse generator implantable
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Intended Purpose

The neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. The device model 3660 is MR conditional.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 05, 2022
Effective Date
October 05, 2022
Manufacturer
Country
United States of America
Address
6901 Preston Road, Plano, Texas, 75024