PMA P130008S031
- Device
- Model 4340 Respiratory Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S031
- Product code
- MNQ
- Decision date
- 2019-01-28
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for a new Model 4340 Respiratory Sensing Lead.
Current openFDA PMA Record#
- Device
- Model 4340 Respiratory Sensing Lead
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S031
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2019-01-28
- Decision code
- APPR
- Date received
- 2017-12-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new Model 4340 Respiratory Sensing Lead.