Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S021 · decided 2017-06-23
Approval details
- PMA number
- P130008
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire II Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2017-03-29
- Decision date
- 2017-06-23
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval to expand the Apnea Hypopnea Index (AHI) range from 20 to 65, to 15 to 65 events per hour.
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