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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.
 
DeviceWiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Generic NameLeadless Cardiac Resynchronization Therapy (CRT)
ApplicantEBR Systems, Inc.
480 Oakmead Pkwy.
Sunnyvale, CA 94085
PMA NumberP240028
Supplement NumberS006
Date Received02/25/2026
Decision Date03/27/2026
Product Code SEG 
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  
qualification of a new supplier for the IrOx coating process on the needle tip of the WiSE CRT System
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