BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P850051 · Supplement: S051 · Decision Oct 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable
    Trade Name
    MEDTRONIC SINGLE CHAMBER PACEMAKERS
    PMA Number
    P850051
    Supplement Number
    S051
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 31, 1995
    Date Received
    July 10, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER.

    Classifications

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

    Product Code Device Name
    LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable