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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 ACE VASCULAR CLOSURE DEVICE (6F/7F)
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Avenue
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS047
Date Received12/31/2012
Decision Date08/19/2013
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DELIVERY SYSTEM THAT COMPOSES THE MYNXGRIP VASCULAR CLOSURE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNX ACE VASCULAR CLOSURE DEVICE ("MYNX ACE") AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIALACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES UTILIZING A 5F, 6F OR 7F PROCEDURAL SHEATH.
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