PMA P130008S041
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S041
- Product code
- MNQ
- Decision date
- 2019-07-22
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for a change in the method used to incorporate serial numbers inside the Model 4063 leads IS-1 connector boot.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation System
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S041
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-07-22
- Decision code
- APPR
- Date received
- 2019-04-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the method used to incorporate serial numbers inside the Model 4063 leads IS-1 connector boot.