BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P010002 · Supplement: S004 · Decision Nov 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Tissue Adhesive For The Topical Approximation Of Skin
    Trade Name
    INDERMIL TISSUE ADHESIVE
    PMA Number
    P010002
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    MPN
    Generic Name
    Tissue adhesive for the topical approximation of skin
    Regulation Number
    878.4010
    Medical Specialty
    General, Plastic Surgery
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 12, 2003
    Date Received
    May 19, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPN Tissue Adhesive For The Topical Approximation Of Skin