BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S003 · Decision Mar 13, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV II DR AICD
    PMA Number
    P960040
    Supplement Number
    S003
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 13, 1998
    Date Received
    November 4, 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(TM) II DR pulse generator Models 1821 and 1826, Model 2843 Application Software, Version 1.3 and revisions to the Physician's Manual, Package Labeling and Patient's Manual.