PMA P130008S064
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S064
- Product code
- MNQ
- Decision date
- 2021-04-09
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Replace a component on the sensor capsule burn-in fixture and increase the sensor capsule burn-in fixture capacity.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S064
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2021-04-09
- Decision code
- OK30
- Date received
- 2021-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace a component on the sensor capsule burn-in fixture and increase the sensor capsule burn-in fixture capacity.