BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S023 · Decision Apr 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    PHILOS DR-T PULSE GENERATOR
    PMA Number
    P950037
    Supplement Number
    S023
    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
    April 2, 2002
    Date Received
    February 11, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PULSE GENERATOR TO ALLOW TRANSMISSION OF DIAGNOSTIC INFORMATION, AND FOR CHANGES TO THE PROGRAMMER SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PHILOS DR-T PULSE GENERATOR AND B-K00.T.U PROGRAMMER SOFTWARE, AND HAS THE SAME INDICATIONS AS THE CURRENTLY MARKETED PHILOS DR. SPECIFICALLY: 1) RATE ADAPTIVE PACING WITH PHILOS DR-T PULSE GENERATORS IS INDICATED FOR PATIENTS EXHIBITING CHRONOTROPIC INCOMPETENCE AND WHO WOULD BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH PHYSICAL ACTIVITY. 2) 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