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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
Generic NameAblation catheter, renal denervation
ApplicantRecor Medical, Inc.
1049 Elwell Ct.
Palo Alto, CA 94303
PMA NumberP220023
Supplement NumberS003
Date Received09/26/2024
Decision Date10/25/2024
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 to implement a change to the supplier and material of the Paradise Catheter strain relief component
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