Inspire Medical Systems, Model 2580 Patient Programmer
FDA premarket approval P130008/S069 · decided 2021-12-18
Approval details
- PMA number
- P130008
- Supplement
- S069
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Medical Systems, Model 2580 Patient Programmer
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-05-28
- Decision date
- 2021-12-18
- Days to decision
- 204 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the Model 2580 Sleep Remote as a replacement for the Model 2500 Sleep Remote.
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