BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950029 · Supplement: S024 · Decision Sep 2, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORCHESTRA PROGRAMMER
    PMA Number
    P950029
    Supplement Number
    S024
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 2, 2005
    Date Received
    July 5, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING SOFTWARE UPDATES: 1) AAISAFER RAM PATCH 2.3 FOR SYMPHONY DR 2550 DEVICES WITH ROM MASK T3, 2) ROM MASK T4 FOR SYMPHONY DR 2550, SYMPHONY SR 2250, ELA RHAPSODY+ DR 2530, ELA RHAPSODY DR 2510, AND ELA RHAPSODY SR 2210, 3) ELAVIEW 1.30 UG2 APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator