|
Device | THE MYNX VASCULAR CLOSURE DEVICE PRODCUT FAMILY |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S055 |
Date Received | 04/10/2014 |
Decision Date | 05/08/2014 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MANUFACTURING PROCESS CHANGES FOR CUTTING AND DRYING THE HYDROGEL CAKES OF THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. |