PMA P130008S069
- Device
- Inspire Medical Systems, Model 2580 Patient Programmer
- Applicant
- Inspire Medical Systems
- Product code
- MNQ
- Decision date
- 2021-12-18
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for the Model 2580 Sleep Remote as a replacement for the Model 2500 Sleep Remote.
Current openFDA PMA Record#
- Device
- Inspire Medical Systems, Model 2580 Patient Programmer
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S069
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2021-12-18
- Decision code
- APPR
- Date received
- 2021-05-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 2580 Sleep Remote as a replacement for the Model 2500 Sleep Remote.