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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, Device Accessories Skin Preparati
Generic NameWearable automated external defibrillator
ApplicantElement Science, Inc.
301 Chesapeake Dr.
Redwood City, CA 94063
PMA NumberP230022
Supplement NumberS006
Date Received12/19/2025
Decision Date01/13/2026
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  
the use of an alternate supplier for a coating process
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