BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Supplement: S024 · Decision Feb 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Over-The-Counter Automated External Defibrillator
    Trade Name
    HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A)
    PMA Number
    P160029
    Supplement Number
    S024
    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
    February 21, 2024
    Date Received
    January 23, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for a battery manufacturing site located at Panasonic Energy Mexico, S.A. de C.V., Escobedo N.L., Mexico

    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