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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.
 
DeviceMYNX VASCULAR CLOSURE DEVICE PRODUCT FAMILY (MYNX PRODUCT FAMILY)
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Avenue
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS049
Date Received08/14/2013
Decision Date03/28/2014
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE HYDROGEL CONDITIONING CYCLE RECIPE.
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