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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
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantCLOSURE MEDICAL CORP.
5265 CAPITAL BLVD.
RALEIGH, NC 27616
PMA NumberP960052
Supplement NumberS007
Date Received10/09/2003
Decision Date12/01/2003
Reclassified Date 05/05/2008
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
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE TO MODIFY A WARNING STATEMENT (6TH BULLET) TO READ, "HIGH VISCOSITY DERMABOND ADHESIVE SHOULD NOT BE USED IN HIGH SKIN TENSION AREAS OR ACROSS AREAS OF INCREASED SKIN TENSION, SUCH AS KNUCKLES, ELBOWS, OR KNEES, UNLESS THE JOINT WILL BE IMMOBILIZED DURING THE SKIN HEALING PERIOD OR UNLESS SKIN TENSION HAS BEEN REMOVED BY APPLICATION OF ANOTHER WOUND CLOSURE DEVICE (E.G., SUTURES OR SKIN STAPLES) PRIOR TO THE APPLICATION OF HIGH VISCOSITY DERMABOND ADHESIVE."
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