BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S071 · Decision Sep 17, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    SYNERGYST II PULSE GENERATOR
    PMA Number
    P890003
    Supplement Number
    S071
    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 17, 2003
    Date Received
    August 19, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 2490D/E CARELINK MONITORS AND MODEL 2491 DDMA SOFTWARE TO ALLOW THEIR USE WITH THE INSYNC ICD MODEL 7272 & INSYNC MARQUIS MODEL 7277. THE CARELINK SYSTEM IS INDICATED FOR USE BY A PATIENT TO INTERROGATE THEIR IMPLANTED DEVICE, AND TRANSFER THE DATA TO A PRIVATE, SECURE SERVER BY USE OF A STANDARD (ANALOG) TELEPHONE CONNECTION.

    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