BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S064 · 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
    S064
    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
    July 2, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO ELECTRICAL DESIGN CHANGES FOR THE LIFEVEST WEARABLEDEFIBRILLATOR 4000 MONITOR PULSE DELIVERY CIRCUITRY. THESE CHANGES INCLUDE AND INCREASE THE VALUES OF FOUR DC BLOCKING CAPACITORS ON THE DEFIBRILLATOR PCA AND TWO BULK CAPACITORS ON THE MONITOR COMPUTER/ANALOG (C/A) BOARD, AS WELL AS CHANGE THE DC BLOCKING CAPACITOR DIELECTRIC FROM Y5V TO X7R AND THE ADDITION OF FERRITE BEAD TO THE BATTERY POWER WIRE ON THE C/A BOARD. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WEARABLE DEFIBRILLATOR 4000 AND IS INDICATED FOR ADULT PATIENTSWHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE 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