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AXONICS SNM SYSTEMโ„ข Neurostimulator F15 Model 4101 - Stimulator, electrical, neuromuscular, incontinence, implantable

Access comprehensive regulatory information for AXONICS SNM SYSTEMโ„ข 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 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.

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TGA ARTG Official Data
Class III
Class III
AXONICS SNM SYSTEMโ„ข Neurostimulator F15 Model 4101 - Stimulator, electrical, neuromuscular, incontinence, implantable
Australia TGA ARTG Registered Device
Good Name: Plexus RA Pty Ltd - AXONICS SNM SYSTEMโ„ข Neurostimulator F15 Model 4101 - Stimulator, electrical, neuromuscular, incontinence, implantable
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Intended Purpose

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.

Device Classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
May 16, 2024
Effective Date
May 16, 2024
Manufacturer
Country
United States of America
Address
26 Technology Drive, Irvine, California, 92618