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

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S009 · Decision May 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Dermal Replacement
    Trade Name
    INTEGRA DERMAL REGENERATION TEMPLATE
    PMA Number
    P900033
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    MDD
    Generic Name
    Device, dermal replacement
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 5, 2003
    Date Received
    April 16, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT, 2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING, 3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND 4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.

    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