BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980023 · Supplement: S016 · Decision Mar 12, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    KENTROX SL ICD LEADS
    PMA Number
    P980023
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 12, 2004
    Date Received
    September 15, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN COMPONENT DIMENSIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME KENTROX SL AND IS INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THIS LEAD SYSTEM WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)