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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 (ORIGINAL AND PRE-MIXED)
Generic NameSealant, polymerizing
ApplicantAngiotech Medical Device Technologies
3600 S.W 47th Ave.
Gainesville, FL 32608
PMA NumberP010022
Supplement NumberS003
Date Received03/26/2003
Decision Date05/06/2003
Withdrawal Date03/15/2012
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFIED REAL-TIME STABILITY PROTOCOLS AND REAL-TIME COMMERCIAL LOT AGING PROTOCOLS TO INCLUDE MECHANICAL AND VISCOSITY TESTING.
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