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AXONICS SNM SYSTEM™ Tined Lead 2201 - Sacral plexus percutaneous incontinence-control electrical stimulation system electrode

ARTG ID: 325940 · 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™ Tined Lead 2201 - Sacral plexus percutaneous incontinence-control electrical stimulation system electrode

Device classification
Risk Class
Class III
Product Type
Single Device Product
ARTG Category
General
Registration information
ARTG ID
325940
Start Date
November 06, 2019
Effective Date
November 06, 2019
Sponsor
Manufacturer
Country
United States of America
Address
26 Technology Drive, Irvine, California, 92618
Intended purpose

The AXONICS SNM SYSTEM™ Tined Lead is an implantable 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 tined lead connects to a stimulation device, which creates a series of electrical pulses to stimulate the sacral nerve. The tined lead kit includes accessories used during implantation of the tined lead.

About this record

Access comprehensive regulatory information for AXONICS SNM SYSTEM™ Tined Lead 2201 - Sacral plexus percutaneous incontinence-control electrical stimulation system electrode in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 325940 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.

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