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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), MYNX CONTROL Vascular Closure Device (5F, 6F/7F), MYNX CONTROL VENOUS Vasc
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS106
Date Received10/18/2024
Decision Date11/15/2024
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a shipping configuration change for the MynxGrip, Mynx Control and Mynx Control Venous Vascular Closure Devices (VCD)
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