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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/24/1996
Decision Date08/26/1998
Reclassified Date 05/05/2008
Product Code
MPN[ Registered Establishments with MPN ]
Docket Number 98M-0879
Notice Date 10/27/1998
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
This device is indicated for topical application to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond(tm) may be used in conjunction with, but not in place of, subcuticular sutures.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012