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

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Supplement: S029 · Decision Feb 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S029
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 2, 2026
    Date Received
    January 5, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an update from the current manual manufacturing method to a semi-automated manufacturing method

    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