BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Implantable, Dual-Chamber

    PMA: P980049 · Supplement: S109 · Decision Jun 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Defibrillator, Implantable, Dual-Chamber
    Trade Name
    ORCHESTRA AND ORCHESTRA PLUS PROGRAMMER
    PMA Number
    P980049
    Supplement Number
    S109
    Device Class
    FDA Class 3
    Product Code
    MRM
    Generic Name
    DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 24, 2016
    Date Received
    March 30, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for hardware modifications to the REPLY / ESPRIT pacemaker platform.

    Classifications

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

    Product Code Device Name
    MRM Defibrillator, Implantable, Dual-Chamber