MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F
FDA premarket approval P040044/S097 · decided 2024-06-27
Approval details
- PMA number
- P040044
- Supplement
- S097
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2023-11-30
- Decision date
- 2024-06-27
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for the MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F for expanding the indications to include venous multiple access closure.
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