Model 2740 Programmer Cable Printed Circuit Board Assembly
FDA premarket approval P130008/S095 · decided 2023-04-28
Approval details
- PMA number
- P130008
- Supplement
- S095
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Model 2740 Programmer Cable Printed Circuit Board Assembly
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2023-01-30
- Decision date
- 2023-04-28
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for the change to the Model 2740 Programmer Cable Printed Circuit Board Assembly (PCBA).
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