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    FDA PMA Number P200037, ASSURE Wearable Cardioverter Defibrillator (WCD) System

    FDA PMA Number P200037, ASSURE Wearable Cardioverter Defibrillator (WCD) System

    $149.00 USD
    $149.00 USD
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    Contents: PMA submission P200037

    Request Year: 2021

    PMA Number: P200037
    Device: ASSURE Wearable Cardioverter Defibrillator (WCD) System
    Generic Name: Wearable automated external defibrillator
    Manufacturer: Kestra Medical Technologies, Inc.
    Product Code: MVK
    Date Received: 08/13/2020
    Decision Date: 07/27/2021
    Notice Date: 07/29/2021

    NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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