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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceBAROSTIM NEO® System
Classification Namestimulator, carotid sinus nerve
Generic Namestimulator, carotid sinus nerve
Regulation Number870.3850
Applicant
CVRx, INC.
9201 west broadway ave, ste 650
minneapolis, MN 55445
PMA NumberP180050
Date Received12/20/2018
Decision Date08/16/2019
Product Code
DSR[ Registered Establishments with DSR ]
Docket Number 19M-3862
Notice Date 08/16/2019
Advisory Committee Cardiovascular
Clinical Trials NCT02627196
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for The BAROSTIM NEO System. The device is indicated for the improvement of symptoms of heart failure. quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction <= 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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