BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Tissue Adhesive For The Topical Approximation Of Skin

    PMA: P010002 · Supplement: S002 · Decision Jun 28, 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
    INDERMIL TISSUE ADHESIVE
    PMA Number
    P010002
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 28, 2002
    Date Received
    May 29, 2002
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    PACKAGING CHANGE FROM A 5 AND 20 UNIT DOSE CONFIGURATION TO A NEW 12 AND 24 UNIT DOSE CONFIGURATION. THE PACKAGING CHANGES WILL MAKE GREATER USE OF THE SPACE WITHIN THE PACKAGING AND ALLOW MORE UNITS TO BE SHIPPED IN THE SAME OR SLIGHTLY INCREASED VOLUME PACKAGING.

    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