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

    PMA: P010031 · Supplement: S092 · Decision Feb 21, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC MARQUIS, INSYNC 2 & 3 MARQUIS, INSYNC 2 &3 PROTECT INSYNC SENTRY FAMILY, INSYNC MAXIMO FAMILY, CONCERTO
    PMA Number
    P010031
    Supplement Number
    S092
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 21, 2008
    Date Received
    January 25, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE CLEANING PROCESS FOR TITANIUM SHIELDS AT MEDTRONIC APPROVED SUPPLIER, GTM GLOBE.