Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S073 · decided 2021-09-10
Approval details
- PMA number
- P130008
- Supplement
- S073
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Inspire II Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-08-13
- Decision date
- 2021-09-10
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the revised protocol for the post-approval study (PAS) protocol.
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