- Device
- Inspire Model 4340 Respiratory Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S075
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2021-11-03
- Decision code
- OK30
- Date received
- 2021-10-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional weld equipment, inspections and rework steps in the manufacturing of the Inspire model 4340 Respiratory Sensing Lead.