|
Device | MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S048 |
Date Received | 02/22/2013 |
Decision Date | 05/17/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order 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. |