PMA P130008S138
- Device
- Inspire V Printed Circuit Board Assembly (PCBA) Test System SW
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S138
- Product code
- MNQ
- Decision date
- 2026-04-16
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Changes to the PCBA Test System to improve manufacturing yield and throughput
Current openFDA PMA Record#
- Device
- Inspire V Printed Circuit Board Assembly (PCBA) Test System SW
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S138
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-04-16
- Decision code
- OK30
- Date received
- 2026-03-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the PCBA Test System to improve manufacturing yield and throughput