BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S056 · Decision Dec 17, 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
    S056
    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
    December 17, 2015
    Date Received
    February 19, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    15M-3521

    Advisory Committee Statement

    APPROVAL FOR THE LIFEVEST WEARABLE CARDIOVERTER DEFIBRILLATOR, MODELS 3000, 3100, AND 4000. THE LIFEVEST SYSTEM IS INDICATED FOR PATIENTS 18 YEARS OF AGE AND OLDER WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. THE LIFEVEST SYSTEM ISINDICATED FOR PATIENTS UNDER 18 YEARS OF AGE WHO ARE AT RISK FOR SUDDEN CARDIAC ARREST AND ARE NOT CANDIDATES FOR OR REFUSE AN IMPLANTABLE DEFIBRILLATOR. PATIENTS MUST HAVE A CHEST CIRCUMFERENCE OF 26 INCHES (66 CENTIMETERS) OR GREATER AND A WEIGHT OF 18.75 KILOGRAMS (41.3 POUNDS) OR GREATER.

    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