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Proclaim 5 IPG, Model 3661 - Analgesic spinal cord electrical stimulation system pulse generator implantable - ARTG 396981

Access comprehensive regulatory information for Proclaim 5 IPG, Model 3661 - 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 registered under ARTG number 396981 and 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
ARTG 396981
Class III
Proclaim 5 IPG, Model 3661 - Analgesic spinal cord electrical stimulation system pulse generator implantable
ARTG ID: 396981
Good Name: Abbott Medical Australia Pty Ltd - Proclaim 5 IPG, Model 3661 - Analgesic spinal cord electrical stimulation system pulse generator implantable
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Intended Purpose

The Implantable Pulse Generator, a component within a Spinal Cord Stimulation system, is designed to deliver low intensity electrical impulses to nerve structures. The neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain, angina pectoris and peripheral vascular disease.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
396981
Start Date
October 05, 2022
Effective Date
October 05, 2022
Manufacturer
Country
United States of America
Address
6901 Preston Road, Plano, Texas, 75024