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

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

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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

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