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

    PMA: P010031 · Supplement: S406 · Decision Nov 19, 2013
    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 CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S406
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 19, 2013
    Date Received
    October 24, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REMOVE THE ANNUAL REQUIREMENT FOR ETHYLENE OXIDE RESIDUAL TESTING AT MEDTRONIC FINAL DEVICE MANUFACTURING FACILITIES.