PMA P130008S126
- Device
- Inspire® Upper Airway Stimulation (UAS)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S126
- Product code
- MNQ
- Decision date
- 2025-06-18
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- addition of a new packaging supplier for the PCBA of the Model 3150
Current openFDA PMA Record#
- Device
- Inspire® Upper Airway Stimulation (UAS)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S126
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2025-06-18
- Decision code
- OK30
- Date received
- 2025-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a new packaging supplier for the PCBA of the Model 3150