BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S013 · Decision Feb 22, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SMARTMAGNET(TM)
    PMA Number
    P980016
    Supplement Number
    S013
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 22, 2001
    Date Received
    August 30, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 9322 SMARTMAGNET(TM). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTMAGNET(TM) AND IS INDICATED FOR KEEPING MEDTRONIC ICDS FROM DELIVERING INAPPROPRIATE THERAPY, SUCH AS SHOCKS, TO PATIENTS DURING SURGICAL PROCEDURES THAT REQUIRE CAUTERY OR OTHER ELECTRICALLY NOISY DEVICES.