ARTG 448867AXONICS SNM SYSTEM™ Neurostimulator F15 Model 4101 - Stimulator, electrical, neuromuscular, incontinence, implantable
ARTG ID: 448867 · Plexus RA Pty Ltd · Axonics Inc · Class III · Started May 16, 2024
Good Name: Plexus RA Pty Ltd - AXONICS SNM SYSTEM™ Neurostimulator F15 Model 4101 - Stimulator, electrical, neuromuscular, incontinence, implantable
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 448867
- Start Date
- May 16, 2024
- Effective Date
- May 16, 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 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 F15 Model 4101 - 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 448867 and sponsored by Plexus RA Pty Ltd, manufactured by Axonics Inc in United States of America. The device registration started on May 16, 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.