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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 NumberS010
Date Received07/01/2008
Decision Date08/18/2008
Product Code NBE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE 3 ML SYRINGE FOR THE PEG COMPONENT OF THE 2 ML CONFIGURATION OF THE DEVICE.
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