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

    PMA: P010031 · Supplement: S289 · Decision Mar 5, 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
    S289
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 5, 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

    ALIGN THE PRODUCTION PROCESSES FOR THE DEVICES WITH THOSE USED FOR APPROVED PREDECESSOR PRODUCTS.