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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 CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 N.W 60th Ave.
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS097
Date Received11/30/2023
Decision Date06/27/2024
Product Code MGB 
Docket Number 24M-3091
Notice Date 07/08/2024
Advisory Committee Cardiovascular
Clinical TrialsNCT05554471
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the MYNX CONTROL™ Venous Vascular Closure Device (VCD) 6F-12F for expanding the indications to include venous multiple access closure.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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