BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Supplement: S009 · Decision Sep 24, 2004
    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
    S009
    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
    September 24, 2004
    Date Received
    August 19, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY AND TO ANOTHER KNOWN METHOD OF STERILIZATION LOCATED AT STERIGENICS (FORMERLY IBA/GRIFFITH), CHARLOTTE, NORTH CAROLINA.

    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