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

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S046 · Decision Apr 22, 2015
    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
    S046
    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
    April 22, 2015
    Date Received
    March 23, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES.

    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