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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 NumberS003
Date Received09/10/2025
Decision Date10/03/2025
Product Code SEG 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an additional energy calibration inspection for the Transmitter subassembly
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