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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.
 
DeviceJewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class
Generic NameWearable automated external defibrillator
ApplicantElement Science, Inc.
301 Chesapeake Dr.
Redwood City, CA 94063
PMA NumberP230022
Supplement NumberS002
Date Received08/28/2025
Decision Date11/18/2025
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 minor design changes to the PCBA assembly enclosure and alternative materials used in the PCB
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