BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S006 · Decision Aug 31, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV III DR PULSE GENERATOR AND VENTAK AV DR SOFTWARE APPLICATION
    PMA Number
    P960040
    Supplement Number
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 31, 1998
    Date Received
    April 22, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the VENTAK(R) AV III DR AICD(TM) System with Model 2843 Software, Version 2.6, the use of Version 2.6 with the VENTAK(R) AV II DR System and modifications to the Physician's Manual and the DR System and modifications tot he Physicians's Manual and the Patient's Manual.