BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P900033 · Supplement: S115 · Decision Sep 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    INTEGRA® Dermal Regeneration Template, Integra® Meshed Dermal Regeneration Template, and Integra® Omnigraft Dermal Regen
    PMA Number
    P900033
    Supplement Number
    S115
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 9, 2025
    Date Received
    August 18, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    reclassifying cleanroom for Integra Dermal Regeneration Template (IDRT) product family

    Classifications

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

    Product Code Device Name
    MGR Dressing, Wound And Burn, Interactive