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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 TOPICAL SKIN ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametopical tissue adhesive
Regulation Number878.4010
ApplicantCLOSURE MEDICAL CORP.
PMA NumberP960052
Supplement NumberS006
Date Received05/01/2003
Decision Date06/13/2003
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two changes to the labeling: 1) change the instructions for use to state that two layers of adhesive should be applied instead of three layers and 2) the addition of language stating that the device can act as a barrier to microbial penetration when intact.
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