BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Supplement: S006 · Decision Jun 13, 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
    DERMABOND TOPICAL SKIN ADHESIVE
    PMA Number
    P960052
    Supplement Number
    S006
    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
    June 13, 2003
    Date Received
    May 1, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO CHANGES TO THE LABELING: 1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND 2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT.

    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