Mynx Control Vascular Closure Device
FDA premarket approval P040044/S109 · decided 2025-05-09
Approval details
- PMA number
- P040044
- Supplement
- S109
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Mynx Control Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2025-04-11
- Decision date
- 2025-05-09
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- labeling changes to comply with the current standards, EU Medical Device Regulations and UK Medical Device Regulations.
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