BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S004 · Decision Jul 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    BELOS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
    PMA Number
    P980023
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    DTA
    Generic Name
    TESTER, PACEMAKER ELECTRODE FUNCTION
    Regulation Number
    870.3720
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 12, 2001
    Date Received
    April 27, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW ICD SYSTEM THAT INCLUDES THE FOLLOWING: BELOS VR ICD (MODEL 330 444), BELOS TEST HOUSING (MODEL 331 116), AND BELOS VR PHYLAX XM/MYCROPHYLAX/PHYLAX 06/TMS 1000 APPLICATION SOFTWARE 1-K01.0.A (MODEL 338 045). THE DEVICE, AS MODIFIED IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION, FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

    Classifications

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

    Product Code Device Name
    DTA Tester, Pacemaker Electrode Function