BEUDAMED
    FDA PMA FDA Class 3 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P010016 · Decision Aug 31, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    ORCEL BILAYERED CELLULAR MATRIX
    PMA Number
    P010016
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision Code
    APCV
    Decision Date
    August 31, 2001
    Date Received
    March 5, 2001
    Expedited Review
    N
    Docket Number
    01M-0413

    Advisory Committee Statement

    APPROVAL FOR THE ORCE BILAYERED CELLULAR MATRIX. THE DEVICE IS INDICATED FOR THE TREATMENT OF FRESH, CLEAN SPLIT THICKNESS DONOR SITE WOUNDS IN BURN PATIENTS.

    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