BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P200037 · Supplement: S004 · Decision Oct 25, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    Assure Wearable Cardioverter Defibrillator (WCD) system
    PMA Number
    P200037
    Supplement Number
    S004
    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
    October 25, 2022
    Date Received
    June 2, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a revision to the software system to version 5.0 with a feature to provide additional information to the physician about the patients health.

    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