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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOSEAL SURGICAL SEALANT
Generic NameSealant, polymerizing
ApplicantBAXTER BIO SCIENCE
32650 N WILSON RD
MAIL STOP WG2-3S
ROUND LAKE, IL 60073
PMA NumberP030039
Supplement NumberS014
Date Received09/04/2009
Decision Date12/18/2009
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview 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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