BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Supplement: S002 · Decision Apr 4, 2001
    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 (2-OCTYL CYANOACRYLATE)
    PMA Number
    P960052
    Supplement Number
    S002
    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
    April 4, 2001
    Date Received
    March 12, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE LABELING IN ORDER TO CLARIFY THE INSTRUCTIONS FOR PREPARING AND STORING THE DEVICE.

    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