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

    Dressing, Wound And Burn, Interactive

    PMA: P900033 · Supplement: S082 · Decision Aug 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    INTEGRA Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Interga Omnigraft Dermal Regenerat
    PMA Number
    P900033
    Supplement Number
    S082
    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
    August 8, 2019
    Date Received
    July 10, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Reduce the sample size for Bacterial Endotoxin Testing for Integra products in conformance with ANSI/AAMI ST-072 standard.

    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