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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 Spyral™ Multi-Electrode Renal Denervation Catheter, Symplicity G3™ Renal Devervation RF Generator
Generic NameAblation catheter, renal denervation
ApplicantMedtronic Inc.
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP220026
Supplement NumberS001
Date Received12/18/2023
Decision Date02/15/2024
Product Code QYI 
Advisory Committee Cardiovascular
Clinical TrialsNCT05198674
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study Spyral AFFIRM (New-Enrollment Registry Study)
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