BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S004 · Decision Dec 4, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV DDD FAMILY OF AICD SYSTEMS
    PMA Number
    P960040
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 4, 1997
    Date Received
    December 2, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    Approval for Software Application Model 2833 Version 3.0 which corrects a hardware limit anomaly.