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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 NameHIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametopical tissue adhesive
Regulation Number878.4010
ApplicantETHICON, INC.
PMA NumberP960052
Supplement NumberS010
Date Received02/09/2005
Decision Date03/21/2005
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of propen and propen xl applicators. The device, as modified, will be marketed under the trade names high viscosity dermabond propen topical adhesive and high viscosity dermabond propen xl topical skin adhesive products and are indicated for topical application 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 propen and propen xl may be used in conjunction with, but not in place of subcuticular sutures. Dermabond adhesive may be used in conjunction with, but not in place of deep dermal stitches.
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