BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S361 · Decision Apr 23, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONSULTA CRT-D, MAXIMO II CRT-D, CONCERTO 11 CRT-D, CPMCERTP CRT-D
    PMA Number
    P010031
    Supplement Number
    S361
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 23, 2014
    Date Received
    February 21, 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 MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.