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

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Decision Aug 26, 1998
    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
    DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
    PMA Number
    P960052
    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
    August 26, 1998
    Date Received
    December 24, 1996
    Expedited Review
    Y
    Docket Number
    98M-0879

    Advisory Committee Statement

    This device is indicated for topical application to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DermaBond(TM) may be used in conjunction with, but not in place of, subcuticular sutures.

    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