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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, PREMIXED
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 NumberS002
Date Received01/17/2006
Decision Date11/03/2006
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BAXTER HEALTHCARE CORPORATION, HAYWARD, CALIFORNIA.
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