Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S061 · decided 2020-12-07
Approval details
- PMA number
- P130008
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire II Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2020-09-08
- Decision date
- 2020-12-07
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for dimensional change on a component of the pressure sensor assembly of the Model 4340 Sensing Lead.
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