- Device
- Inspire IV IPG
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S053
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-06-18
- Decision code
- OK30
- Date received
- 2020-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Software update (Version 2.0) to the Hybrid Test System software and new Hybrid Test System hardware equipment for testing of the Model 3028 Implantable Pulse Generator.