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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCOSEAL SURGICAL SEALANT, PREMIXED
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
ApplicantBAXTER HEALTHCARE CORP.
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
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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