BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Supplement: S020 · Decision Dec 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Over-The-Counter Automated External Defibrillator
    Trade Name
    HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)
    PMA Number
    P160029
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    NSA
    Generic Name
    Over-the-counter automated external defibrillator
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 19, 2023
    Date Received
    September 22, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a 30-month shelf-life for the HS1 SMART Pads.

    Classifications

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

    Product Code Device Name
    NSA Over-The-Counter Automated External Defibrillator