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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 NameEXOSEAL VASCULAR CLOSURE DEVICE
Classification Namedevice, hemostasis, vascular
ApplicantCORDIS CORPORATION
PMA NumberP100013
Supplement NumberS009
Date Received04/09/2013
Decision Date05/09/2013
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the processing of three components from single cavity mold to multi cavity molds for the exoseal vascular closure device.
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