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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 NameMYNX VASCULAR CLOSURE DEVICE WITH GRIP TECHNOLOGY
Classification Namedevice, hemostasis, vascular
ApplicantACCESS CLOSURE, INC.
PMA NumberP040044
Supplement NumberS034
Date Received09/30/2010
Decision Date10/04/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modified version of the mynx vascular closure device called the mynx vascular closure device with grip technology.
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