PMA P130008S082
- Device
- Inspire Patient Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S082
- Product code
- MNQ
- Decision date
- 2022-04-01
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Notification of implementing automated final functional testing for the Model 2580 Patient Remote.
Current openFDA PMA Record#
- Device
- Inspire Patient Remote
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S082
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-04-01
- Decision code
- OK30
- Date received
- 2022-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Notification of implementing automated final functional testing for the Model 2580 Patient Remote.