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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDERMABOND TOPICAL SKIN ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametopical tissue adhesive
Regulation Number878.4010
ApplicantCLOSURE MEDICAL CORP.
PMA NumberP960052
Supplement NumberS007
Date Received10/09/2003
Decision Date12/01/2003
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
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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