BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S022 · Decision Oct 26, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    AXIOS PULSE GENERATOR FAMILY/B-K05.S.U PROGRAMMER SOFTWARE
    PMA Number
    P950037
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 26, 2001
    Date Received
    September 28, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE AXIOS FAMILY OF PULSE GENERATORS AND THE B-K05.S.U PROGRAMMER SOFTWARE. THE AXIOS PULSE GENERATORS ARE INDICATED AS FOLLOWS: 1) RATE-ADAPTIVE PACING WITH AXIOS PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) GENERALLY ACCEPTED INDICATIONS FOR LONG-TERM CARDIAC PACING INCLUDE, BUT ARE NOT LIMITED TO: SICK SINUS SYNDROME (I.E. BRADYCARDIA-TACHYCARDIA SYNDROME, SINUS ARREST, SINUS BRADYCARDIA), SINO-ATRIAL (SA) BLOCK, SECOND- AND THIRD- DEGREE AV BLOCK, AND CAROTID SINUS SYNDROME. 3) PATIENTS WHO DEMONSTRATE HEMODYNAMIC BENEFIT THROUGH MAINTENANCE OF AV SYNCHRONY SHOULD BE CONSIDERED FOR ONE OF THE DUAL CHAMBER OR ATRIAL PACING MODES. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE BOTH RESTORATION OF RATE AND AV SYNCHRONY SUCH AS AV NODAL DISEASE, DIMINISHED CARDIAC OUTPUT OR CONGESTIVE HEART FAILURE ASSOCIATED WITH CONDUCTION DISTURBANCES, AND TACHYARRHYTHMIAS THAT ARE SUPPRESSED BY CHRONIC PACING.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode