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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.
 
Trade NameDERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametopical tissue adhesive
Regulation Number878.4010
ApplicantCLOSURE MEDICAL CORP.
PMA NumberP960052
Supplement NumberS004
Date Received05/01/2001
Decision Date12/31/2002
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a higher viscosity product. The device, as modified, will be marketed under the trade name high viscosity dermabond topical skin adhesive and is intended for topical application only 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 adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
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