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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceARTERX SURGICAL SEALANT
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP100030
Date Received07/27/2010
Decision Date03/01/2013
Product Code NBE 
Docket Number 13M-0281
Notice Date 03/14/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00759681
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE ARTERX SURGICAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S004 S005 S007 S008 S009 S010 S011 S013 S014 
S015 S016 S017 S018 
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