- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S060
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-09-29
- Decision code
- OK30
- Date received
- 2020-08-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the Hybrid Test System software from Version 2.0 to Version 2.0.1 to address false test failures due to improper startup of hybrids under test.