BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S053 · Decision May 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Dermal Replacement
    Trade Name
    INTEGRA(R) DERMAL REGENERATION TEMPLATE, INTEGRA(R) MESHED DERMAL REGENERATION TEMPLATE
    PMA Number
    P900033
    Supplement Number
    S053
    Device Class
    FDA Class 3
    Product Code
    MDD
    Generic Name
    Device, dermal replacement
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2016
    Date Received
    November 3, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of two new product sizes (i.e., 4cm x 4cm and 7cm x 7cm) and revised packaging that permits inclusion of a stapler and staples in the Integra Omnigraft Dermal Regeneration Matrix kit. The device, as modified, will be marketed under the trade name Omnigraft Dermal Regeneration Matrix.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MDD Device, Dermal Replacement