BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Over-The-Counter Automated External Defibrillator

    PMA: P160008 · Supplement: S017 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Over-The-Counter Automated External Defibrillator
    Trade Name
    samaritan 350P (SAM350P) Automated External Defibrillator
    PMA Number
    P160008
    Supplement Number
    S017
    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 23, 2022
    Date Received
    March 17, 2022
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change to the Indications for Use (IFU) from prescription to Over-the-Counter (OTC) use with associated labeling changes.

    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