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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 NumberS004
Date Received04/05/2006
Decision Date05/11/2007
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the coseal spray delivery system with a spray set and pressure regulator.
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