BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S014 · Decision Dec 2, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    IMPLANTABLE PACEMAKER LEAD
    PMA Number
    P940008
    Supplement Number
    S014
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 2, 1999
    Date Received
    October 25, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the manufacturing and labeling facility located at Guidant Corp., St. Paul, MN 55112-5798.