BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Dressing, Wound And Burn, Interactive

    PMA: P950032 · Supplement: S072 · Decision Jul 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Dressing, Wound And Burn, Interactive
    Trade Name
    APLIGRAF
    PMA Number
    P950032
    Supplement Number
    S072
    Device Class
    FDA Class 3
    Product Code
    MGR
    Generic Name
    Dressing, wound and burn, interactive
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 11, 2013
    Date Received
    April 24, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTRODUCTION OF HUMAN EPIDERMAL KERATINOCYTE CELLSTRAIN 197 (HEP 197) FOR USE IN THE MANUFACTURE OF APLIGRAF, AND FOR APPROVAL OF A CHANGE FROM THE CURRENT TEST ASSAY FOR DETECTION OF CERTAIN VIRAL CONTAMINANTS TO A REAL-TIME PCR METHOD FROM A CONVENTIONAL GEL-BASED PCR METHOD.

    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