BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980049 · Supplement: S001 · Decision May 18, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    DEFENDER IV MODEL 612 DUAL-CHAMBER, RATE-RESPONSIVE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, ELA MEDICAL PROMGRAMMER
    PMA Number
    P980049
    Supplement Number
    S001
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 18, 2000
    Date Received
    October 15, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for Defender IV DR Model 612.