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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade Name5F & 6/7F MYNX VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Supplement NumberS032
Date Received05/20/2010
Decision Date06/17/2010
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the instructions for use to apply light fingertip compression proximal to the insertion site before deflating and removing the balloon catheter.
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