PMA P130008S130

Device: Inspire® Upper Airway Stimulation
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S130
Product code: MNQ
Decision date: 2025-10-22
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130008/S089

Current openFDA PMA Record#

Device: Inspire® Upper Airway Stimulation
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S130
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-10-22
Decision code: APPR
Date received: 2025-09-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P130008/S089