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

    PMA: P010031 · Supplement: S290 · Decision Feb 29, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4 DEVICES (D314TRM, D334TRM, D204TRM AND D264TRM)
    PMA Number
    P010031
    Supplement Number
    S290
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 29, 2012
    Date Received
    February 9, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR FOUR MANUFACTURING CHANGES: 1) RF MODULE SOLDER FLUX CLEAN ADDITION; 2) FLUX INSPECTION CHANGE; 3) RADIO FREQUENCY DEVICE TEST UPDATE; AND 4) A MANUFACTURING SITE MOVE FOR 8-PIN FILTERS.