BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Decision Jun 6, 2019
    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
    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
    June 6, 2019
    Date Received
    July 29, 2016
    Expedited Review
    N
    Docket Number
    19M-2782

    Advisory Committee Statement

    Approval for the HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A). The HeartStart OnSite Defibrillator (M5066A) is indicated for use on potential victims of sudden cardiac arrest with the following symptoms:1) Unconsciousness; and 2) Absence of normal breathing.The HeartStart OnSite (Model M5066A) is indicated for adults over 55 pounds (25 kg). It is also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child SMART pads. If Infant/Child SMART pads are not available, or you are uncertain of the childs age or weight, proceed with treatment using adult SMART pads.The HeartStart Home Defibrillator (M5068A) is indicated for use on potential victims of cardiac arrest with the following symptoms: 1) Unconsciousness; and 2) Absence of normal breathing. The HeartStart Home (M5068A) is indicated for adults over 55 pounds (25 kg). They are also indicated for infants and children under 55 lbs (25 kg) or 8 years old when used with the optional infant/child SMART pads. If Infant/Child SMART pads are not available, or you are uncertain of the childs age or weight, proceed with treatment using adult 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