Australia TGA ARTG recordAXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control
Australia TGA ARTG Registered Device · Axonics Modulation Technologies Australia Pty Ltd · Axonics Inc · Class III · Started November 06, 2019
Good Name: Axonics Modulation Technologies Australia Pty Ltd - AXONICS SNM SYSTEM™ Remote Control 2301 - Incontinence-control electrical stimulation system, nonimplantable, remote control
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- November 06, 2019
- Effective Date
- November 06, 2019
- Name
- Axonics Inc
- Country
- United States of America
- Address
- 26 Technology Drive, Irvine, California, 92618
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.
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 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.