PMA P130008S049
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S049
- Product code
- MNQ
- Decision date
- 2020-01-16
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for updates to the Inspire System Implant Manual.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S049
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-01-16
- Decision code
- APPR
- Date received
- 2019-12-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Inspire System Implant Manual.