BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S011 · Decision Aug 22, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS
    PMA Number
    P980035
    Supplement Number
    S011
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 22, 2001
    Date Received
    July 16, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ALTERNATE MANUFACTURING, PACKAGING AND STERILIZATION FACILITIES AT MEDTRONIC BV, THE NETHERLANDS AND MEDTRONIC EUROPE S.A., TOLOCHENAZ, SWITZERLAND.