BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S039 · Decision Dec 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Wearable Automated External Defibrillator
    Trade Name
    LIFEVEST WEARABLE DEBRILLATOR
    PMA Number
    P010030
    Supplement Number
    S039
    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 20, 2012
    Date Received
    November 21, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR:1) DESIGN MODIFICATIONS TO THE MONITOR ENCLOSURE; 2) ADDITION OF EP11HT GRAY EPOXY TO THE HIGH VOLTAGE CAPACITOR SOLDER JOINTS; AND3) ADDITION OF LOCTITE 3536 EPOXY UNDERFILL TO THE BALL GRID ARRAY COMPONENTS OF THE PRINTED CIRCUIT ASSEMBLIES

    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