Inspire Upper Airway Stimulator
FDA premarket approval P130008/S033 · decided 2018-05-15
Approval details
- PMA number
- P130008
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2018-02-14
- Decision date
- 2018-05-15
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for proposed changes to the Inspire systems MRI Guidelines Manual.
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