Mynx Control Vascular Control Device (5F, 6F/7F)
FDA premarket approval P040044/S094 · decided 2023-07-13
Approval details
- PMA number
- P040044
- Supplement
- S094
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Mynx Control Vascular Control Device (5F, 6F/7F)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2023-04-17
- Decision date
- 2023-07-13
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for minor design and material modifications to the deployment button on the Mynx Control Vascular Closure Devices.
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