MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)
FDA premarket approval P040044/S054 · decided 2014-06-18
Approval details
- PMA number
- P040044
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2014-04-03
- Decision date
- 2014-06-18
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR DESIGN AND MANUFACTURING PROCESS CHANGES TO THE O-RING COMPONENT FOR THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY.
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