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

    PMA: P010031 · Supplement: S260 · Decision Jul 15, 2011
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II/CONSULTA/MAXIMO II
    PMA Number
    P010031
    Supplement Number
    S260
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 15, 2011
    Date Received
    June 10, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    SIX CHANGES TO GEN2 HYBRID TESTER: 1) A CHANGE TO THE TEST DECIBEL LIMIT OF THE EGM CMR; 2) A CHANGE TO THE TELEMETRY B VIZSENSE; 3) A CHANGE TO THE R034 STRESS; 4) A CHANGE TO THE JTAG FULL ENERGY DELIVERY PULSE WIDTH; 5) A CHANGE TO LV1 CONTINUITY; AND 6) A CHANGE TO THE CURRENT DRAIN AVVD RF IDD.