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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 NumberS004
Date Received06/02/2022
Decision Date10/25/2022
Product Code MVK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a revision to the software system to version 5.0 with a feature to provide additional information to the physician about the patients health.
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