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

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S167 · Decision Oct 11, 2023
    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
    S167
    Device Class
    FDA Class 3
    Product Code
    MVK
    Generic Name
    Wearable automated external defibrillator
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 11, 2023
    Date Received
    September 15, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the implementation of automated, electrical functional test systems employed during manufacture of the LifeVest Monitor and Electrode Belt printed circuit assemblies (PCAs) at the existing supplier

    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