PMA P130008S121

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S121
Product code: MNQ
Decision date: 2025-05-09
Classification: Anesthesiology
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement: change to the Model 3150 header attach step allowing primed titanium EMAs (Electronic Module Assembly) to be stored for up to ten days prior to being processed through the header attach step

Current openFDA PMA Record#

Device: INSPIRE II UPPER AIRWAY STIMULATOR
Applicant: Inspire Medical Systems
PMA number: P130008
Supplement: S121
Product code: MNQ
Generic name: Stimulator, hypoglossal nerve, implanted, apnea
Decision date: 2025-05-09
Decision code: OK30
Date received: 2025-04-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: change to the Model 3150 header attach step allowing primed titanium EMAs (Electronic Module Assembly) to be stored for up to ten days prior to being processed through the header attach step