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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.
 
DeviceCOSEAL SURGICAL SEALANT
Generic NameSealant, polymerizing
ApplicantBAXTER BIO SCIENCE
32650 N WILSON RD
MAIL STOP WG2-3S
ROUND LAKE, IL 60073
PMA NumberP030039
Date Received07/16/2003
Decision Date12/12/2003
Product Code NBE 
Docket Number 03M-0560
Notice Date 12/31/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR REFERENCE RIGHTS TO P010022. THE 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 S003 S004 S005 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S019 S020 S021 S022 S023 S024 S025 S026 
S027 S028 
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