BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P010002 · Decision May 22, 2002
    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(TM) TISSUE ADHESIVE
    PMA Number
    P010002
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    May 22, 2002
    Date Received
    February 1, 2001
    Expedited Review
    N
    Docket Number
    03M-0040

    Advisory Committee Statement

    APPROVAL FOR THE INDERMIL TISSUE ADHESIVE. THE DEVICE IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. INDERMIL 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