INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM
FDA premarket approval P130008/S009 · decided 2016-06-02
Approval details
- PMA number
- P130008
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INSPIRE UPPER AIRWAY STIMULATION THERAPY SYSTEM
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2015-11-12
- Decision date
- 2016-06-02
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the Model 2500 Sleep Remote (i.e. patient programmer).
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