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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.
Classification Namesealant,polymerizing
PMA NumberP100030
Supplement NumberS004
Date Received05/22/2014
Decision Date07/31/2014
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a product trade name change from arterx® surgical sealant to preveleak surgical sealant. The device, as modified, will be marketed under the trade name preveleak surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.