BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S086 · Decision Apr 25, 2017
    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) 3000, 3100, 4000.
    PMA Number
    P010030
    Supplement Number
    S086
    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
    April 25, 2017
    Date Received
    October 27, 2016
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the Zoll Wearable Cardioverter Defibrillator (WCD) 3000, 3100, and 4000 Operators Manuals to reflect the results of the Post-Approval Study.

    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