Australia TGA ARTG recordInspire Stimulation Lead Model 4063 - Implantable sleep apnoea treatment system
Australia TGA ARTG Registered Device · Plexus RA Pty Ltd · Inspire Medical Systems Inc · Class III · Started August 06, 2020
Good Name: Plexus RA Pty Ltd - Inspire Stimulation Lead Model 4063 - Implantable sleep apnoea treatment system
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- August 06, 2020
- Effective Date
- August 06, 2020
- Country
- United States of America
- Address
- 5500 Wayzata Blvd Suite 1600 Golden Valley, Minnesota, 55416
The Inspire Stimulation Lead Model 4063 is part of the Inspire Upper Airway Stimulation therapy system that is intended to treat moderate to severe obstructive sleep apnoea (15 ≤ AHI ≤ 65), in patients who are not effectively treated by, or able to tolerate, positive airway pressure (PAP) therapies, by improving airway patency through stimulation of the hypoglossal nerve, synchronous with respiration, to elicit a neuromuscular response at the base of the tongue.
Access comprehensive regulatory information for Inspire Stimulation Lead Model 4063 - Implantable sleep apnoea treatment system 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 Inspire Medical Systems Inc in United States of America. The device registration started on August 06, 2020.
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.