BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950029 · Decision Mar 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
    PMA Number
    P950029
    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
    March 10, 1997
    Date Received
    August 2, 1995
    Expedited Review
    N
    Docket Number
    97M-0185

    Advisory Committee Statement

    APPROVAL FOR THE CHORUS RM MODEL 7034 DDDR PACEMAKER SYSTEM AND OPUS RM MODEL 4534 SSIR PACEMAKER SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD. THESE DEVICES ARE INDICATED FOR: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: *SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREEE AV BLOCK; *SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; *SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; *BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND *VASO-VAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE CHROUS RM IS ALSO INDICATED FOR DUAL-CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL-CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY WHICH INCLUDE: *VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND *VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.

    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