Inspire Upper Airway Stimulation System
FDA premarket approval P130008/S090 · decided 2023-06-08
Approval details
- PMA number
- P130008
- Supplement
- S090
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire Upper Airway Stimulation System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2022-10-17
- Decision date
- 2023-06-08
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval to expand the indications for use to OSA patients with an upper limit baseline apnea-hypopnea index (AHI) to 100 (increase from <= 65 to <=100) and increasing the an upper limit body mass index (BMI) warning to 40 (increase from <=32 to <=40).
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