BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S420 · Decision Apr 11, 2014
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D
    PMA Number
    P010031
    Supplement Number
    S420
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2014
    Date Received
    January 24, 2014
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPDATES TO THE HYBRID TEST PROCESS.