BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Tester, Pacemaker Electrode Function

    PMA: P980023 · Supplement: S005 · Decision Oct 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Tester, Pacemaker Electrode Function
    Trade Name
    TEROX RV /KAINOX SL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR/LEAD MODELS
    PMA Number
    P980023
    Supplement Number
    S005
    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
    October 24, 2001
    Date Received
    June 25, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE LEGALLY MARKETED KAINOX RV AND KAINOX SL LEAD SYSTEMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEROX RV 65 (MODEL 332 232), TEROX RV 75 (MODEL 332 231),KAINOX SL 65/13 (MODEL 124 235),KAINOX SL 65/16 (MODEL 124 236), KAINOX SL 65/18 (MODEL 124 237), AND IS INDICATED FOR USE WITH LEGALLY MARKETED BIOTRONIK IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD).

    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