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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 TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE)
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantClosure Medical Corp.
5265 Capital Blvd.
Raleigh, NC 27616
PMA NumberP960052
Supplement NumberS002
Date Received03/12/2001
Decision Date04/04/2001
Reclassified Date05/05/2008
Product Code MPN 
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 TO MODIFY THE LABELING IN ORDER TO CLARIFY THE INSTRUCTIONS FOR PREPARING AND STORING THE DEVICE.
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