ARTG 462565AXONICS SNM SYSTEM™ Neurostimulator R20 Model 5101 - Stimulator, electrical, neuromuscular, incontinence, implantable
ARTG ID: 462565 · Axonics Modulation Technologies Australia Pty Ltd · Axonics Inc · Class III · Started September 23, 2024
Good Name: AXONICS SNM SYSTEM™ Neurostimulator R20 Model 5101 - Stimulator, electrical, neuromuscular, incontinence, implantable
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 462565
- Start Date
- September 23, 2024
- Effective Date
- September 23, 2024
- Name
- Axonics Inc
- Country
- United States of America
- Address
- 26 Technology Drive, Irvine, California, 92618
For urinary control therapy: The Neurostimulator is a programmable implantable device intended for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. For bowel therapy: The Neurostimulator is a programmable implantable device intended for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments.
Access comprehensive regulatory information for AXONICS SNM SYSTEM™ Neurostimulator R20 Model 5101 - Stimulator, electrical, neuromuscular, incontinence, implantable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 462565 and sponsored by Axonics Modulation Technologies Australia Pty Ltd, manufactured by Axonics Inc in United States of America. The device registration started on September 23, 2024.
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.