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AXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control - ARTG 325941

Access comprehensive regulatory information for AXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 325941 and sponsored by Axonics Modulation Technologies Australia Pty Ltd, manufactured by Axonics Inc in United States of America. The device registration started on November 06, 2019.

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 325941
Class III
AXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control
ARTG ID: 325941
Good Name: Axonics Modulation Technologies Australia Pty Ltd - AXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control
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Intended Purpose

The AXONICS SNM SYSTEM™ Remote Control is a nonimplantable accessory to the nonimplantable AXONICS SNM SYSTEM Trial Stimulator and to the Axonics Neurostimulator AIMD, both of which are intended to treat urinary and/or faecal incontinence. The remote control is used to establish connection to an implantable neurostimulator or a nonimplantable trial stimulator to check the device stimulation level and/or battery status; adjust the stimulation level within a clinician-pre-configured range; inform users of device errors.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
325941
Start Date
November 06, 2019
Effective Date
November 06, 2019
Manufacturer
Country
United States of America
Address
26 Technology Drive, Irvine, California, 92618