PMA P130008S123

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S123
Product code: MNQ
Decision date: 2026-08-28
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: Approval for updates to the production endotoxin sampling plan for the Model 3150 Implanted Pulse Generator (IPG).

Current openFDA PMA Record#

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S123
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2026-08-28
Decision code: APPR
Date received: 2025-04-25
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updates to the production endotoxin sampling plan for the Model 3150 Implanted Pulse Generator (IPG).