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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 NumberS001
Date Received05/19/2025
Decision Date06/18/2025
Product Code SEG 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of the The WiSE-UP Registry (The WiSE System Utilization & Performance Registry) post-approval study protocol
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