BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S020 · Decision Sep 5, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC GEM DR MODEL 7271
    PMA Number
    P980016
    Supplement Number
    S020
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2001
    Date Received
    August 6, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ALTERNATE MANUFACTURING AND STERILIZATION FACILITY LOCATED AT MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND AND AN ALTERNATE PACKAGING FACILITY LOCATED AT MEDTRONIC BV, KERKRADE, THE NETHERLANDS.