BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S006 · Decision Mar 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    BELOS VR ICD SYSTEM
    PMA Number
    P980023
    Supplement Number
    S006
    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
    March 11, 2002
    Date Received
    February 4, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PROGRAMMER SOFTWARE CARTRIDGE I-K01.0.A/4, MINOR EMBEDDED SOFTWARE CHANGES, MINOR HARDWARE CHANGES, AND A CORRECTION TO THE "USE BEFORE" DATE.

    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