BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S007 · Decision Nov 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    LIFEVEST (WCD 3100) DEVICE
    PMA Number
    P010030
    Supplement Number
    S007
    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 1, 2006
    Date Received
    March 6, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR HARDWARE CHANGE TO INTEGRATE THE PENDANT ALARM MODULE INTO THE MONITOR ENCLOSURE, HARDWARE CHANGE TO THE COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY TO IMPROVE EMI IMMUNITY AND REPLACE SEVERAL OBSOLETE COMPONENTS, SOFTWARE CHANGES TO INTERACT WITH THE REVISED COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, LABELING CHANGES TO ACCOMMODATE THE INTEGRATED ALARM MODULE, AND TO IMPROVE READABILITY, LABELING CHANGES TO PROVIDE A SPANISH VERSION OF THE PATIENT MANUAL, PATIENT CHECKLIST, AND CORRESPONDING AUDIO/DISPLAY MESSAGES FOR SPANISH SPEAKING PATIENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LIFEVEST WCD 3100 AND IS INDICATED FOR ADULT PATIENTS WHO 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