- Device
- Inspire® Upper Airway Stimulation (UAS)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S115
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2024-12-10
- Decision code
- OK30
- Date received
- 2024-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the battery tab weld fixture that is used by Inspire’s final device manufacturer, Osypka Medtec Inc. (OMI). A visual inspection was added as a result of this change