BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S170 · Decision Feb 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    LifeVest® Wearable Defibrillator
    PMA Number
    P010030
    Supplement Number
    S170
    Device Class
    FDA Class 3
    Product Code
    MVK
    Generic Name
    Wearable automated external defibrillator
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 14, 2024
    Date Received
    November 7, 2023
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    labeling changes associated with 5G cellular immunity to the Instruction for Use (IFU) manuals for the LifeVest 5100 system: LifeVest 5100 Patient Manual (US English), LifeVest 5100 Patient Manual SUS (US Spanish), LifeVest 5100 Clinical Manual, and LifeVest 5100 Field Manual

    Classifications

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

    Product Code Device Name
    MVK Wearable Automated External Defibrillator