BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S003 · Decision May 1, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
    PMA Number
    P980023
    Supplement Number
    S003
    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
    May 1, 2000
    Date Received
    November 2, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for: 1) the introduction of Patient data Manager Softward, PDM 2000, and 2) a new method for determining the Use Before Date of Biotronik's ICDs.

    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