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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 NameCOSEAL SURGICAL SEALANT
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP030039
Supplement NumberS011
Date Received08/29/2008
Decision Date09/26/2008
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for addition of safety related statements to the labeling.
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