PMA P130008S120

Device
Inspire® Upper Airway Stimulation (UAS)
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S120
Product code
MNQ
Decision date
2025-04-23
Classification
Anesthesiology
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Approval order statement
notification of a change to the weld block plating supplier

Current openFDA PMA Record#

Device
Inspire® Upper Airway Stimulation (UAS)
Applicant
Inspire Medical Systems
PMA number
P130008
Supplement
S120
Product code
MNQ
Generic name
Stimulator, hypoglossal nerve, implanted, apnea
Decision date
2025-04-23
Decision code
OK30
Date received
2025-03-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
notification of a change to the weld block plating supplier