BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S145 · Decision Aug 5, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC FAMILIES OF ICDS/CONCERTO/MAXIMO II/CONSULTA FAMILIES OF CRT-DS
    PMA Number
    P010031
    Supplement Number
    S145
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 5, 2009
    Date Received
    February 18, 2009
    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 CHANGING A STERILIZATION SPECIFICATION FOR FINISHED DEVICE MANUFACTURING.