MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
FDA premarket approval P040044/S048 · decided 2013-05-17
Approval details
- PMA number
- P040044
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cordis US Corporation
- Date received
- 2013-02-22
- Decision date
- 2013-05-17
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- APPROVAL FOR CLARIFICATION AND SIMPLIFICATION OF THE LANGUAGE USED INTHE INSTRUCTION FOR USE AND REMOVAL OF THE STERILIZATION INDICATOR LABEL FROM THE DEVICE POUCH FOR THE MYNX CADENCE VASCULAR CLOSURE DEVICE, 6F/7F MYNXGRIP VASCULAR CLOSURE DEVICE, AND 5F MYNXGRIP VASCULAR CLOSURE DEVICE.
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