PMA P130008S080
- Device
- Inspire Model 2580 Sleep Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S080
- Product code
- MNQ
- Decision date
- 2022-03-16
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Addition of a manufacturing site for the inductor coil used in the Model 2580 remote.
Current openFDA PMA Record#
- Device
- Inspire Model 2580 Sleep Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S080
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-03-16
- Decision code
- OK30
- Date received
- 2022-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a manufacturing site for the inductor coil used in the Model 2580 remote.