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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 NumberS014
Date Received09/04/2009
Decision Date12/18/2009
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for a change in the materials used to make the syringe that holds the polyethylene glycol (pig) polymers.
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