PMA P130008S023
- Device
- Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S023
- Product code
- MNQ
- Decision date
- 2017-07-28
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for a change to the feedthrough component of the Model 4323 Sensing Lead.
Current openFDA PMA Record#
- Device
- Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S023
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2017-07-28
- Decision code
- APPR
- Date received
- 2017-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the feedthrough component of the Model 4323 Sensing Lead.