PMA P130008S118
- Device
- Inspire Upper Airway Stimulation (UAS) system
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S118
- Product code
- MNQ
- Decision date
- 2025-02-14
- Classification
- Anesthesiology
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- for labeling changes to add warning for the use of Inspire UAS during an MRI scan
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation (UAS) system
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S118
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2025-02-14
- Decision code
- APPR
- Date received
- 2025-01-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- for labeling changes to add warning for the use of Inspire UAS during an MRI scan