|
Device | MYNXGRIP VASCULAR CLOSURE DEVICE (MYNXGRIP) |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S066 |
Date Received | 09/09/2015 |
Decision Date | 12/03/2015 |
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 |
Approval Order Statement APPROVAL FOR AN EXTENSION OF SHELF LIFE FROM ONE YEAR TO TWO YEARS. |