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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceASSURE Wearable Cardioverter Defibrillator (WCD) System
Generic NameWearable automated external defibrillator
ApplicantKestra Medical Technologies, Inc.
3933 Lake Washington Blvd. NE
Suite 200
Kirkland, WA 98033
PMA NumberP200037
Supplement NumberS001
Date Received09/15/2021
Decision Date11/19/2021
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a software update in the off-the-shelf software and resolution of unresolved anomalies.
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