PMA P130008S066
- Device
- Inspire Upper Airway Stimulation (UAS)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S066
- Product code
- MNQ
- Decision date
- 2021-06-11
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Replacement component in the pressure sensor capsule from a new supplier.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation (UAS)
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S066
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2021-06-11
- Decision code
- OK30
- Date received
- 2021-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement component in the pressure sensor capsule from a new supplier.