BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P910020 · Supplement: S020 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MOMENTUM PACERS
    PMA Number
    P910020
    Supplement Number
    S020
    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
    January 30, 1998
    Date Received
    January 8, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Mementum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock(TM) pulse generator models.

    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