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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
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
BAXTER 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[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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