PMA P130008S040
- Device
- Inspire Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S040
- Product code
- MNQ
- Decision date
- 2019-03-06
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Move manufacturing activities for the Model 2740 Physician Programmer to Nortech Systems.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulator
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S040
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-03-06
- Decision code
- OK30
- Date received
- 2019-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move manufacturing activities for the Model 2740 Physician Programmer to Nortech Systems.