Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
• Generic Name: tissue adhesive for the topical approximation of skin
• Regulation Number: 878.4010
• Applicant: CLOSURE MEDICAL CORP.; 5265 capital blvd.; raleigh, NC 27616
• PMA Number: P960052
• Date Received: 12/24/1996
• Decision Date: 08/26/1998
• Reclassified Date: 05/05/2008
• Product Code: 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