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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceHISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantTISSUE SEAL LLC
5643 Plymouth Rd
Ann Arbor, MI 48105
PMA NumberP050013
Date Received03/25/2005
Decision Date02/16/2007
Reclassified Date 05/05/2008
Product Code MPN 
Docket Number 07M-0086
Notice Date 03/16/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE. THE DEVICE IS INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF MINIMUM-TENSION WOUNDS FROM CLEAN SURGICAL INCISIONS AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE MAY BE USED IN CONJUNCTION WITH BUT NOT IN PLACE OF DERMAL SUTURES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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