Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F) |
Generic Name | Device, hemostasis, vascular |
Applicant | Cordis US Corporation 14201 NW 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P040044 |
Supplement Number | S068 |
Date Received | 12/07/2015 |
Decision Date | 09/06/2016 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at 9020 Activity Road, Suite D, San Diego, California, 92126 for the sterilization of the Mynx Grip Vascular Closure Device (5F/6F/7F) and Mynx Ace Vascular Closure Device (5F/6F/7F). |
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