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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.
 
DeviceSymplicity G3 Renal Denervation RF Generator
Generic NameAblation catheter, renal denervation
ApplicantMedtronic, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP220026
Supplement NumberS019
Date Received09/25/2026
Decision Date10/23/2026
Product Code QYI 
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  
approval for replacement of manufacturing lines and inspection process changes for circuit boards in the Symplicity G3 Renal Denervation RF Generator
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