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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
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Ave.
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS056
Date Received05/02/2014
Decision Date07/30/2014
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day 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 TO EXPAND THE INDICATIONS FOR USE TO INCLUDE CLOSURE OF VENOUS ACCESS SITES IN ADDITION TO THE CURRENTLY APPROVED USE FOR CLOSURE OF ARTERIAL ACCESS SITES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MYNXGRIP VASCULAR CLOSURE DEVICE AND IS INDICATED FOR USE TO SEAL FEMORAL ARTERIAL AND FEMORAL VENOUS ACCESS 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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