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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 & ACCESSORIES
Generic NameSealant, polymerizing
ApplicantBaxter Bio Science
32650 N Wilson Rd.
Mail Stop Wg2-3s
Round Lake,, IL 60073
PMA NumberP030039
Supplement NumberS015
Date Received03/02/2010
Decision Date04/05/2010
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 CHANGES TO THE LABELING TO ADDRESS SAFETY-RELATED INFORMATION TO BRING THE LABELING INTO COMPLIANCE WITH THE EUROPEAN MEDICAL DEVICE DIRECTIVE MDD 2007/47/EC.
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