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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCOSEAL SURGICAL SEALANT
Classification Namesealant,polymerizing
ApplicantBAXTER BIO SCIENCE
PMA NumberP030039
Date Received09/09/2003
Decision Date12/12/2003
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 03M-0560
Notice Date 12/31/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Review Memo Review Memo
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S011 S012 S013 
S014 S015 S016 
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