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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 MINI APPLICATOR
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantClosure Medical Corp.
5265 Capital Blvd.
Raleigh, NC 27616
PMA NumberP960052
Supplement NumberS011
Date Received12/16/2005
Decision Date02/10/2006
Reclassified Date05/05/2008
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE DESIGN CHANGE OF THE HIGH VISCOSITY DERMABOND APPLICATOR SO THAT IT HAS A REDUCED FILL VOLUME COMPARED TO THE ORIGINAL HIGH VISCOSITY DERMABOND APPLICATOR (0.325 GRAMS RATHER THAN -.565 GRAMS OF THE ORIGINAL PRODUCT). THE DEVICE, HIGH VISCOSITY DERMABOND MINI APPLICATOR, AS MODIFIED, IS INDICATED FOR ?TOPICAL APPLICATION TO HOLD CLOSED APPROXIMATED WOUND EDGES OF TRAUMA INDUCED LACERATIONS OR SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, THAT OTHERWISE COULD BE CLOSED WITH SUTURES OF U.S.P. SIZE 5-0 OR SMALLER DIAMETER, STAPLES, OR ADHESIVE STRIPS AND THAT DO NOT REQUIRE4 TOPICAL MEDICATIONS AFTER CLOSURE.?
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