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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINDERMIL TISSUE ADHESIVE
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantCOVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
150 GLOVER AVE.
NORWALK, CT 06856
PMA NumberP010002
Supplement NumberS004
Date Received05/19/2003
Decision Date11/12/2003
Reclassified Date 05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A CANNULA TO THE APPLICATOR AND A MICROBIAL BARRIER CLAIM TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDERMIL. TISSUE ADHESIVE AND IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC SKIN INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. IN VITRO STUDIES HAVE ALSO SHOWN THAT INDERMIL MAY ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN THE ADHESIVE FILM REMAINS UNBROKEN. INDERMIL TISSUE ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.
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