BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S026 · Decision Feb 5, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Device, Dermal Replacement
    Trade Name
    INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
    PMA Number
    P900033
    Supplement Number
    S026
    Device Class
    FDA Class 3
    Product Code
    MDD
    Generic Name
    Device, dermal replacement
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 2015
    Date Received
    April 26, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE IN CLEANING DETERGENT FOR CERTAIN EQUIPMENT;2) CHANGE IN CLEANING METHOD FOR CERTAIN EQUIPMENT, UTILIZING ISOPROPYL ALCOHOL;3) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIME (DHT); AND 4) ESTABLISHMENT OF A METHOD TO TEST FOR RESIDUES.

    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