BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S015 · Decision Oct 5, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    LEAD CAP ACCESSORY KIT
    PMA Number
    P940008
    Supplement Number
    S015
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 5, 2000
    Date Received
    June 26, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LEAD CAPS FOR USE WITH ALL GUIDANT COMPATIBLE LEADS INCLUDING THE RELIANCE(TM) AND RELIANCE S(TM) LEADS.