BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P960052 · Supplement: S011 · Decision Feb 10, 2006
    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
    HIGH VISCOSITY DERMABOND MINI APPLICATOR
    PMA Number
    P960052
    Supplement Number
    S011
    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
    February 10, 2006
    Date Received
    December 16, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE DESIGN CHANGE OF THE HIGH VISCOSITY DERMABOND APPLICATOR SO THAT IT HAS A REDUCED FILL VOLUME COMPARED TO THE ORIGINAL HIGH VISCOSITY DERMABOND APPLICATOR (0.325 GRAMS RATHER THAN -.565 GRAMS OF THE ORIGINAL PRODUCT). THE DEVICE, HIGH VISCOSITY DERMABOND MINI APPLICATOR, AS MODIFIED, IS INDICATED FOR ?TOPICAL APPLICATION TO HOLD CLOSED APPROXIMATED WOUND EDGES OF TRAUMA INDUCED LACERATIONS OR SURGICAL INCISIONS, INCLUDING PUNCTURES FROM MINIMALLY INVASIVE SURGERY, THAT OTHERWISE COULD BE CLOSED WITH SUTURES OF U.S.P. SIZE 5-0 OR SMALLER DIAMETER, STAPLES, OR ADHESIVE STRIPS AND THAT DO NOT REQUIRE4 TOPICAL MEDICATIONS AFTER CLOSURE.?

    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