BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Supplement: S004 · Decision Dec 31, 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
    DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
    PMA Number
    P960052
    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
    December 31, 2002
    Date Received
    May 1, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A HIGHER VISCOSITY PRODUCT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE AND IS INTENDED FOR TOPICAL APPLICATION ONLY TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF WOUNDS FROM SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HIGH VISCOSITY DERMABOND 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