|
Device | MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S034 |
Date Received | 09/30/2010 |
Decision Date | 10/04/2011 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MODIFIED VERSION OF THE MYNX VASCULAR CLOSURE DEVICE CALLED THE MYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY. |