PMA P130008S116

Device: Inspire Upper Airway Stimulation (UAS)
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S116
Product code: MNQ
Decision date: 2025-06-03
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: notification of updated silicone application instructions during the header attach operations of the Model 3028 Implantable Pulse Generator (IPG)

Current openFDA PMA Record#

Device: Inspire Upper Airway Stimulation (UAS)
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S116
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-06-03
Decision code: APPR
Date received: 2024-11-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: notification of updated silicone application instructions during the header attach operations of the Model 3028 Implantable Pulse Generator (IPG)