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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceParadise® Ultrasound Renal Denervation System
Generic NameAblation catheter, renal denervation
ApplicantReCor Medical, Inc.
1049 Elwell Court
Palo Alto, CA 94303
PMA NumberP220023
Date Received10/25/2022
Decision Date11/07/2023
Product Code QYI 
Docket Number 23M-4937
Notice Date 11/16/2023
Advisory Committee Cardiovascular
Clinical TrialsNCT02649426
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Paradise Ultrasound Renal Denervation System is indicated to reduce blood pressure as an adjunctive treatment in hypertension patients in whom lifestyle modifications and antihypertensive medications do not adequately control blood pressure.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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