PMA P130008S074
- Device
- Silicone Stimulation Lead, Silicone Sensing Lead
- Applicant
- Inspire Medical Systems
- Product code
- MNQ
- Decision date
- 2022-04-29
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for the Model 4063 Silicone Stimulation Lead and the Model 4340 Silicone Sensing Lead lengths 25cm and 45cm.
Current openFDA PMA Record#
- Device
- Silicone Stimulation Lead, Silicone Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S074
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2022-04-29
- Decision code
- APPR
- Date received
- 2021-08-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 4063 Silicone Stimulation Lead and the Model 4340 Silicone Sensing Lead lengths 25cm and 45cm.