|
Device | MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. (MYNX PRODUCT FAMILY) |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S054 |
Date Received | 04/03/2014 |
Decision Date | 06/18/2014 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN AND MANUFACTURING PROCESS CHANGES TO THE O-RING COMPONENT FOR THE MYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY. |