BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S059 · Decision Nov 6, 2015
    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
    S059
    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
    November 6, 2015
    Date Received
    December 22, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR:1) REDESIGNED ECG AND BELT NODE PCAS; 2) ADDITION OF A FERRITE BEAD TO THE TRUNK CABLE ASSEMBLY AND MODIFICATION TO THE BELT NODE PLASTIC ENCLOSURE; 3) CONNECTORIZED THERAPY ELECTRODE (TE); 4) THERAPY ELECTRODE GAS GENERATOR PLASTIC ENCLOSURE INSPECTION WINDOW; 5) ADDITION OF AN ACCELEROMETER TO THE FRONT TE AND ADDITIONAL CONDUCTORS TO THE CABLE ASSEMBLIES6) ADDITION OF THE TE ADVISORY LABELS TO THE ELECTRODE BELT.

    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