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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOSEAL SURGICAL SEALANT
Generic NameSealant, polymerizing
ApplicantBAXTER BIO SCIENCE
32650 N WILSON RD
MAIL STOP WG2-3S
ROUND LAKE, IL 60073
PMA NumberP030039
Supplement NumberS003
Date Received02/02/2006
Decision Date03/10/2006
Product Code NBE 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGE TO ADD A WARNING REGARDING USE OF THE SEALANT TO ADHERE OBJECTS TO TISSUE.
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