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

    PMA: P010031 · Supplement: S311 · Decision Jun 25, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D ICDS
    PMA Number
    P010031
    Supplement Number
    S311
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 25, 2012
    Date Received
    May 31, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UPDATE TO THE VENDOR INSPECTION OF A FLEX COMPONENT, A CHANGE TO THE DIE ATTACH CURE PROCESS AND REMOVAL OF PARALLEL GAP WELDING LINE TESTING.