BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950037 · Decision Oct 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
    PMA Number
    P950037
    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
    October 11, 1996
    Date Received
    November 16, 1995
    Expedited Review
    N
    Docket Number
    97M-0251

    Advisory Committee Statement

    RATE ADAPTIVE PACING WITH THE DROMOS DR AND DROMOS SR PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY

    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