INSPIRE II UPPER AIRWAY STIMULATION SYSTEM
FDA premarket approval P130008/S010 · decided 2016-06-01
Approval details
- PMA number
- P130008
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- INSPIRE II UPPER AIRWAY STIMULATION SYSTEM
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2016-03-30
- Decision date
- 2016-06-01
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval of the following changes to the post-approval study for the device: revisions to the protocol to increase the enrollment rate.
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