BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated External Defibrillators (Non-Wearable)

    PMA: P160026 · Supplement: S040 · Decision Apr 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    66

    Basic Information

    Device Name
    Automated External Defibrillators (Non-Wearable)
    Trade Name
    LIFEPAK® 35 Monitor/Defibrillator
    PMA Number
    P160026
    Supplement Number
    S040
    Device Class
    FDA Class 3
    Product Code
    MKJ
    Generic Name
    Automated external defibrillators (non-wearable)
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 12, 2024
    Date Received
    July 18, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a new model of professional-use automated external defibrillator (AED), the LIFEPAK 35 Monitor/Defibrillator, the LIFEPAK Therapy Cable, LIFEPAK FLEX Lithium-Ion Battery and a Predetermined Change Control Plan (PCCP), dated April 10, 2024, for noninvasive blood pressure modules and cleaning modifications.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MKJ Automated External Defibrillators (Non-Wearable)