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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.
 
DeviceParadise™ Ultrasound Renal Denervation System (Paradise System)
Generic NameAblation catheter, renal denervation
ApplicantRecor Medical, Inc.
1049 Elwell Ct.
Palo Alto, CA 94303
PMA NumberP220023
Supplement NumberS011
Date Received05/19/2026
Decision Date08/13/2026
Product Code QYI 
Advisory Committee Cardiovascular
Clinical TrialsNCT02649426
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 revision to the protocol for the Post-Approval Study (PAS) referenced above.
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