BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S010 · Decision Jan 20, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV AICD & VENTAK AV II DDD AICD
    PMA Number
    P960040
    Supplement Number
    S010
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 20, 1999
    Date Received
    January 13, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Software Application Model 2833 Version 3.1 for use with VENTAK(R) AV I/II(TM) DDD AICD(TM) Systems.