BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940008 · Supplement: S016 · Decision Apr 25, 2001
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INTERMEDICS MICRON IMPLANTABLE DEFIBRILLATORS
    PMA Number
    P940008
    Supplement Number
    S016
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 25, 2001
    Date Received
    March 27, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE FOLLOW-UP INDICATORS REFLECTING BATTERY LONGEVITY.