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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
Generic NameDevice, hemostasis, vascular
ApplicantCordis US Corporation
14201 NW 60th Avenue
Miami Lakes, FL 33014
PMA NumberP040044
Supplement NumberS001
Date Received04/06/2006
Decision Date05/16/2007
Product Code MGB 
Docket Number 07M-0285
Notice Date 07/20/2007
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MYNX VASCULAR CLOSURE SYSTEM. THE DEVICE IS INDICTED FOR USE TO SEAL FEMORAL ARTERIAL 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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