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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.
 
DeviceDERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE)
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametissue adhesive for the topical approximation of skin
Regulation Number878.4010
Applicant
CLOSURE MEDICAL CORP.
5265 capital blvd.
raleigh, NC 27616
PMA NumberP960052
Supplement NumberS002
Date Received03/12/2001
Decision Date04/04/2001
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 Product No
Approval Order Statement 
Approval to modify the labeling in order to clarify the instructions for preparing and storing the device.
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