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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceCOSEAL SURGICAL SEALANT
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
Applicant
BAXTER BIO SCIENCE
32650 n wilson rd
mail stop wg2-3s
round lake, IL 60073
PMA NumberP030039
Date Received07/16/2003
Decision Date12/12/2003
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 03M-0560
Notice Date 12/31/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Recalls CDRH Recalls
Approval Order Statement 
Approval for reference rights to p010022. The device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S019 
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