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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic NameWearable automated external defibrillator
ApplicantKestra 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 TrialsNCT03887052
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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