BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S051 · Decision Jul 14, 2014
    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
    S051
    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 14, 2014
    Date Received
    May 12, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A SOFTWARE CHANGE THAT WILL ENABLE ANANALOG CLIPPING NOISE DETECTOR WHICH WILL ALLOW THE SYSTEM TO BETTER RECOGNIZE WHEN AN INPUT SIGNAL MAY BE COMPROMISED DUE TO SATURATION OF ANALOG AMPLIFIERS IN THE ECG SIGNAL PROCESSING CIRCUITRY.

    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