BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S074 · Decision Jul 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 4000 LIFEVEST
    PMA Number
    P010030
    Supplement Number
    S074
    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
    July 18, 2016
    Date Received
    April 19, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a larger capacity battery pack and associated modifications to the battery pack connection to the printed circuit assembly (PCA) for the WCD 4000 System. This device is indicated for patients of all ages who are at risk for sudden cardiac arrest and either not candidates for or refuse an implantable defibrillator.

    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