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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMYNXGRIP VASCULAR CLOSURE DEVICE (5F, 6F/7F)
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS068
Date Received12/07/2015
Decision Date09/06/2016
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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