Inspire Upper Airway Stimulation Therapy
FDA premarket approval P130008/S029 · decided 2018-05-11
Approval details
- PMA number
- P130008
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Inspire Upper Airway Stimulation Therapy
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2017-11-14
- Decision date
- 2018-05-11
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for updates to the labeling with the results of the Extended Follow Up of the Premarket Cohort post approval study.
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