BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acute Coronary Syndrome Event Detector

    PMA: P150009 · Supplement: S009 · Decision Aug 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Acute Coronary Syndrome Event Detector
    Trade Name
    Guardian System
    PMA Number
    P150009
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    QBI
    Generic Name
    Acute coronary syndrome event detector
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 10, 2023
    Date Received
    April 18, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a trade name change to The Guardian System.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QBI Acute Coronary Syndrome Event Detector