BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P950029 · Supplement: S017 · Decision Oct 24, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM
    PMA Number
    P950029
    Supplement Number
    S017
    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 24, 2003
    Date Received
    December 23, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW PACEMAKER MODELS, SYMPHONY MODELS 2550, AND 2250 AND ELA RHAPSODY MODELS 2530, 2510 AND 2210. THE SYMPHONY AND ELA RHAPSODY PACEMAKER SYSTEMS ARE INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND- OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS: D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES (SYMPOHONY DR MODEL 2550 AND ELA RHAPSODY DR MODELS 2530 AND 2510) ARE INDICATED FOR PATITNES 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: 1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND 2) 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