BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960040 · Supplement: S007 · Decision Dec 8, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTAK AV AICD FAMILY SYSTEMS
    PMA Number
    P960040
    Supplement Number
    S007
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 8, 1998
    Date Received
    November 25, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revisions to the Physician's Manuals of the Ventak(R) AV(TM) AICD(TM) Systems.