PMA P130008S051
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S051
- Product code
- MNQ
- Decision date
- 2020-03-02
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Notification of adding an alternate new supplier for the terminal ferrule used in the battery for Model 3028 IPG
Current openFDA PMA Record#
- Device
- Inspire II Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S051
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2020-03-02
- Decision code
- OK30
- Date received
- 2020-01-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Notification of adding an alternate new supplier for the terminal ferrule used in the battery for Model 3028 IPG