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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.
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametissue adhesive for the topical approximation of skin
Regulation Number878.4010
5265 capital blvd.
raleigh, NC 27616
PMA NumberP960052
Supplement NumberS011
Date Received12/16/2005
Decision Date02/10/2006
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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. ?.