BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pacemaker/Icd/Crt Non-Implanted Components

    PMA: P010031 · Supplement: S510 · Decision Oct 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Pacemaker/Icd/Crt Non-Implanted Components
    Trade Name
    MAXIMO II CRT-D, CONCERTO, CONCERTO II, CONSULTA, INSYNC II MARQUIS, INSYNC III MARQUIS, INSYNC MAXIMO, INSYNC SENTRY,
    PMA Number
    P010031
    Supplement Number
    S510
    Device Class
    FDA Class 3
    Product Code
    OSR
    Generic Name
    Pacemaker/icd/crt non-implanted components
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 2015
    Date Received
    August 28, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FIRMWARE UPDATES FOR THE HOME MONITOR SYSTEMS, WHICH WILL BE USED WITH THE IMPLANTABLE DEVICES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OSR Pacemaker/Icd/Crt Non-Implanted Components