BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S372 · Decision Dec 24, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D,& XT CRT-D, BRAVA CRT-D, VIVA S CRT-D
    PMA Number
    P010031
    Supplement Number
    S372
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 24, 2013
    Date Received
    April 10, 2013
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A RE-PACKAGING/RE-LABELING SITE LOCATED AT MEDTRONIC IN MEMPHIS, TENNESEE.