- Device
- Model 4063 Inspire Stimulation Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S136
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-08-28
- Decision code
- APPR
- Date received
- 2026-02-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- The use of new Medical Adhesive (MA) curing ovens at supplier facility to be used in the Model 4063 Stimulation Lead manufacturing process