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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
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP030039
Supplement NumberS008
Date Received11/16/2007
Decision Date12/14/2007
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in supplier and a change to the syringe filling process.
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