|
Device | MYNXGRIP VASCULAR CLOSURE DEVICES |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S059 |
Date Received | 11/12/2014 |
Decision Date | 08/03/2015 |
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 A NEW COEXTRUDED BALLOON SUBASSEMBLY OF THE MYNXGRIP VASCULAR CLOSURE DEVICE. |