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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.
 
DeviceDERMABOND(R) TOPICAL SKIN ADHESIVE
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantClosure Medical Corp.
5265 Capital Blvd.
Raleigh, NC 27616
PMA NumberP960052
Supplement NumberS003
Date Received04/10/2001
Decision Date11/19/2001
Reclassified Date05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day 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 THE ADDITION OF A STATEMENT IN THE LABELING THAT THE DEIVCE PROVIDES MICROBIAL BARRIER PROPERTIES.
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