BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S009 · Decision Nov 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    KAINOX RV-S/ KAINOX VCS ICD LEADS
    PMA Number
    P980023
    Supplement Number
    S009
    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
    November 25, 2002
    Date Received
    June 4, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE KAINOX RV-S ACTIVE FIXATION, SINGLE SHOCK COIL ICD LEAD AND THE KAINOX VCS SINGLE SHOCK COIL ICD LEAD FOR USE AS AN ADJUNCT TO MODIFY THE SHOCK CONFIGURATION OF ICD SYSTEMS. TOGETHER WITH LEGALLY MARKETED BIOTRONIK ICDS, THESE LEAD SYSTEMS PROVIDE THE PATIENT WITH A SYSTEM THAT IS CAPABLE OF DETECTING AND TREATING VENTRICULAR TACHYARRHYTHMIAS.

    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