BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S053 · 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
    S053
    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
    May 27, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTS WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE DEVICE AS MODIFIED IS APPROVED FOR 1) CHANGE TO THE LENGTH OF THE THERAPY ELECTRODE CHANNEL FOAM; 2) CHANGE TO THE DIMENSIONAL TOLERANCES OF THE HOLE LOCATIONS ON THE THERAPY ELECTRODELIDDING LAYER;3) CHANGE FROM ADHESIVE TO CRIMPING OF THE BATTERY CONNECTOR AND REINFORCEMENT OF THE BATTERY CELLS WITHIN THE WCD 4000 PACK; AND4) CHANGE OF MATERIAL OF THE HEX NUT USED IN THE WCD 4000 MONITOR ELECTRODE BELTRECEPTACLE FROM BRASS TO STAINLESS STEEL.

    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