BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Acute Coronary Syndrome Event Detector

    PMA: P150009 · Supplement: S006 · Decision Sep 17, 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
    S006
    Device Class
    FDA Class 3
    Product Code
    QBI
    Generic Name
    Acute coronary syndrome event detector
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 17, 2021
    Date Received
    August 26, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Additional supplier of capacitors used in the EXD 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