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

    Optical Diagnostic Device For Melanoma Detection

    PMA: P090012 · Supplement: S009 · Decision Jul 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Optical Diagnostic Device For Melanoma Detection
    Trade Name
    MELAFIND
    PMA Number
    P090012
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    OYD
    Generic Name
    Optical diagnostic device for melanoma detection
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 7, 2014
    Date Received
    April 29, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDED 3RD PARTY OPERATING SYSTEM INSTALLATION SOFTWARE TO VERSION REGISTRY; AND DEPLOYMENT OF NEW SOFTWARE BUILD AND INSTALLATION WORKSTATIONS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OYD Optical Diagnostic Device For Melanoma Detection