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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 NumberS004
Date Received11/17/2025
Decision Date12/15/2025
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  
to update manufacturing lot release testing requirements for M1000 and M2000 catheters.
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