PMA P130008S142
- Device
- Model 4063 Inspire Stimulation Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S142
- Product code
- MNQ
- Decision date
- 2026-08-11
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- updates to Model 4063 Inspire Stimulation Lead Manufacturing Final Pack and Sterile Packaging work instructions
Current openFDA PMA Record#
- Device
- Model 4063 Inspire Stimulation Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S142
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2026-08-11
- Decision code
- OK30
- Date received
- 2026-07-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to Model 4063 Inspire Stimulation Lead Manufacturing Final Pack and Sterile Packaging work instructions