BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S004 · Decision Dec 9, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC 350 SERIES PACING SYSTEM
    PMA Number
    P980035
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 9, 1999
    Date Received
    November 11, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Medtronic Model 350 Series Pacing System Programmed by the Medtronic Model 9790/C Programmer with Sigma Model 9963/9963A software.