Inspire IV Implantable Pulse Generator Model 3028 - Implantable sleep apnoea treatment system
Access comprehensive regulatory information for Inspire IV Implantable Pulse Generator Model 3028 - 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 December 14, 2022.
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.
The Inspire IV Implantable Pulse Generator Model 3028 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.