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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 NumberS011
Date Received08/29/2008
Decision Date09/26/2008
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDITION OF SAFETY RELATED STATEMENTS TO THE LABELING.
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