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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic Namewearable automated external defibrillator
Applicant
Kestra Medical Technologies, Inc.
3933 lake washington boulevard, n.e.
suite 200
kirkland, WA 98033
PMA NumberP200037
Date Received08/13/2020
Decision Date07/27/2021
Product Code MVK 
Docket Number 21M-0820
Notice Date 07/29/2021
Advisory Committee Cardiovascular
Clinical Trials NCT03887052
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ASSURE system which is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for, or refuse, an implantable defibrillator.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements:  
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