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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™ Catheter
Generic NameAblation catheter, renal denervation
ApplicantRecor Medical, Inc.
1049 Elwell Ct.
Palo Alto, CA 94303
PMA NumberP220023
Supplement NumberS007
Date Received02/18/2025
Decision Date03/06/2025
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  
a change to the supplier of the piezoelectric material block used in manufacturing ultrasound transducers
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