PMA P130008S114
- Device
- Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S114
- Product code
- MNQ
- Decision date
- 2024-11-13
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Updates to the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead sterilization process
Current openFDA PMA Record#
- Device
- Model 4063 Inspire Stimulation Lead, Model 4340 Inspire Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S114
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2024-11-13
- Decision code
- OK30
- Date received
- 2024-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the Model 4063 Stimulation Lead and the Model 4340 Sensing Lead sterilization process