PMA P130008S029
- Device
- Inspire Upper Airway Stimulation Therapy
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S029
- Product code
- MNQ
- Decision date
- 2018-05-11
- Classification
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Approval order statement
- Approval for updates to the labeling with the results of the Extended Follow Up of the Premarket Cohort post approval study.
Current openFDA PMA Record#
- Device
- Inspire Upper Airway Stimulation Therapy
- Applicant
- Inspire Medical Systems
- PMA number
- P130008
- Supplement
- S029
- Product code
- MNQ
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Decision date
- 2018-05-11
- Decision code
- APPR
- Date received
- 2017-11-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for updates to the labeling with the results of the Extended Follow Up of the Premarket Cohort post approval study.