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

    PMA: P010031 · Supplement: S415 · Decision Jan 16, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRAVA CRT-D; CONCERTO II CRT-D; CONSULTA ICD,MAXIMO II CRT-D, PROTECTA XI C RT-D, VIVA S/X CRT-D;
    PMA Number
    P010031
    Supplement Number
    S415
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 16, 2014
    Date Received
    December 19, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    RELOCATION FOR THE PERFORMANCE OF SELECTED INSPECTION ACTIVITIES USED FOR INCOMING/RECEIVING FOR SELECTED MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT (CRDM) PRODUCTS.