BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P840068 · Supplement: S034 · Decision Mar 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    DELTA(R) PACEMAKER SYSTEM (VIGOR SSI AND DDD MODELS ONLY)
    PMA Number
    P840068
    Supplement Number
    S034
    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
    March 27, 1998
    Date Received
    March 4, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design modifications related to the pacemaker top ("header") (including the lead connector, outer sleeve, anchor brackets, x-ray identifier, and laser mark), the sterile tray, and labeling changes to the physician's system manual and outer box labels of the VIGOR Models 950, 1230, and 1232.

    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)