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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.
 
DeviceHIGH VISCOSITY DERMABOND 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 NumberS010
Date Received02/09/2005
Decision Date03/21/2005
Reclassified Date 05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF PROPEN AND PROPEN XL APPLICATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HIGH VISCOSITY DERMABOND PROPEN TOPICAL ADHESIVE AND HIGH VISCOSITY DERMABOND PROPEN XL TOPICAL SKIN ADHESIVE PRODUCTS AND ARE INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF WOUNDS FROM SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HIGH VISCOSITY DERMABOND PROPEN AND PROPEN XL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF SUBCUTICULAR SUTURES. DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF DEEP DERMAL STITCHES.
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