BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Wearable Automated External Defibrillator

    PMA: P010030 · Supplement: S015 · Decision Dec 16, 2009
    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
    S015
    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 16, 2009
    Date Received
    October 30, 2009
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF AN ALTERNATE FLASH/SRAM CHIP FOR USE ON THE WCD 3100, A CORRECTION OF A BILL OF MATERIALS ERROR ON THE WCD 3100 COMPUTER/ANALOG PRINTED CIRCUIT ASSEMBLY, AND TWO DESIGN CHANGES TO THE HIGH VOLTAGE CONVERTER CIRCUIT ON THE DEFIBRILLATOR PRINTED CIRCUIT ASSEMBLY.

    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