BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S002 · Decision Dec 9, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV AICD TM SYSTEM
    PMA Number
    P960040
    Supplement Number
    S002
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 9, 1997
    Date Received
    September 30, 1997
    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 II pulse generator Models 1820 and 1825, Model 2833 Application Software, Version 2.8 and revised labeling to include shock energy as Joules "stored" rather than Joules "delivered".