BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S028 · Decision Jul 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    LIFEVEST WEARABLE BEFIBRILLATOR
    PMA Number
    P010030
    Supplement Number
    S028
    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
    July 7, 2011
    Date Received
    May 10, 2011
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR USE OF THE E-ONE MOLI ENERGY 1HR18650B (2.25AH) LITHIUM-ION BATTERY CELL WITH YOUR LIFEVEST MODEL 4000 WEARABLE 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