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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 NumberS021
Date Received08/31/2026
Decision Date09/28/2026
Product Code MVK 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
an updated workflow for the post-wear data transfer process
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