BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acute Coronary Syndrome Event Detector

    PMA: P150009 · Supplement: S002 · Decision Jun 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Acute Coronary Syndrome Event Detector
    Trade Name
    AngelMed Guardian System
    PMA Number
    P150009
    Supplement Number
    S002
    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
    June 21, 2021
    Date Received
    January 28, 2019
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for changes to the design of the Implantable Medical Device resulting in the AMSG3-E model with a 1-year shelf life and a 3-year implanted life.

    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