MYNX CADENCE VASCULAR CLOSURE DEVICE
FDA premarket approval P040044/S033 · decided 2010-10-22
Approval details
- PMA number
- P040044
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MYNX CADENCE VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2010-08-18
- Decision date
- 2010-10-22
- Days to decision
- 65 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR REMOVING THE INNER CARTRIDGE ASSEMBLY, REDUCING THE ADVANCER TUBE MARKERS TO ONE AND ADDING A SHUTTLE STOP FEATURE.
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