PMA P130008S122

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S122
Product code: MNQ
Decision date: 2025-05-16
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: transfer of Ultrasonic Welder calibration services in-house at the manufacturer of Model 3150 IPG and enhance the calibration process to reduce equipment down time and ensure a more reliable production process

Current openFDA PMA Record#

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S122
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-05-16
Decision code: OK30
Date received: 2025-04-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: transfer of Ultrasonic Welder calibration services in-house at the manufacturer of Model 3150 IPG and enhance the calibration process to reduce equipment down time and ensure a more reliable production process