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

    Over-The-Counter Automated External Defibrillator

    PMA: P160029 · Supplement: S017 · Decision Jul 27, 2022
    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 (M5066A), HeartStart Home Defibrillator (M5068A), HeartStart HS1 SMART Pads, Adult (M507
    PMA Number
    P160029
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 27, 2022
    Date Received
    July 5, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Replace the current Water Spray System on the Hydrogel Heat Cure Line with a new Water Spray System in order to reduce the variation in the final gel water content.

    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