BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Dermal Replacement

    PMA: P900033 · Supplement: S035 · Decision Oct 17, 2014
    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
    S035
    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
    October 17, 2014
    Date Received
    April 11, 2014
    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 IMPLEMENTATION OF MECHANICAL, PROGRAM, AND SYSTEM CONTROL CHANGES TO THE EXISTING CHILLED WATER SYSTEM THAT SERVICES COLLAGEN LYOPHILIZER MACHINES IN THE LYO MANUFACTURING AREA OF BUILDING 1 AT THE INTEGRA NEUROSCIENCES FACILITY IN AÑASCO, PUERTO RICO, 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