|
Device | MYNX VASCULAR CLOSURE DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S008 |
Date Received | 06/03/2008 |
Decision Date | 07/22/2008 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR CHANGING THE METHOD OF ATTACHMENT OF THE TENSION PLUNGER TO THE COREWIRE OF THE MYNX VASCULAR CLOSURE DEVICE TO OVERMOLD THE TENSION PLUNGER DIRECTLY ONTO THE COREWIRE. |