BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Supplement: S018 · Decision Feb 16, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Over-The-Counter Automated External Defibrillator
    Trade Name
    M5071A HS1 Adult SMART Pads Cartridge, M5072A HS1 Infant/Child SMART Pads Cartridge
    PMA Number
    P160029
    Supplement Number
    S018
    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 16, 2023
    Date Received
    November 18, 2022
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design change to implement a strip of double sided tape to the leading edge of the hydrogel layer of 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