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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
ApplicantAngiotech Medical Device Technologies
3600 S.W 47th Ave.
Gainesville, FL 32608
PMA NumberP010022
Supplement NumberS002
Date Received03/05/2003
Decision Date03/18/2003
Withdrawal Date03/15/2012
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
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 A LABELING CHANGE TO ADD A BOXED WARNING REGARDING SWELL VOLUMES OF THE SEALANT.
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