PMA P130008S046
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S046
- Product code
- MNQ
- Decision date
- 2019-09-11
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Notification of changes being implemented to test specification gain limits associated with the manufacture of the Model 4340 Sensing Lead.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S046
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-09-11
- Decision code
- OK30
- Date received
- 2019-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Notification of changes being implemented to test specification gain limits associated with the manufacture of the Model 4340 Sensing Lead.