BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P840068 · Supplement: S019 · Decision Jun 19, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    VISTA DDD MODEL 942 & 944 AND SOFTWARE MODULE MODEL 2052
    PMA Number
    P840068
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 19, 1996
    Date Received
    May 5, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO NEW MODELS OF VISTA DDD PULSE GENERATORS AND A SOFTWARE MODULE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME VISTA DDD MODEL 942, VISTA DDD MODEL 944 AND SOFTWARE MODULE MODEL 2052 WITH THE COMMERCIALLY AVAILABLE HANDHELD PROGRAMMER MODEL 2035

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)