PMA P130008S143

Device: Inspire Upper Airway Stimulation (UAS) System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S143
Product code: MNQ
Decision date: 2026-08-17
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval for a software update to the measuring method used for dimensional inspection of the Model 2740 and Model 2740C Programmer Cables' Top Housing component.

Current openFDA PMA Record#

Device: Inspire Upper Airway Stimulation (UAS) System
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S143
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-08-17
Decision code: OK30
Date received: 2026-07-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a software update to the measuring method used for dimensional inspection of the Model 2740 and Model 2740C Programmer Cables' Top Housing component.