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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.
 
DeviceBAROSTIM NEO® System
Generic Namestimulator, carotid sinus nerve
Regulation Number870.3850
ApplicantCVRx, INC.
9201 west broadway ave, ste 650
minneapolis, MN 55445
PMA NumberP180050
Date Received12/20/2018
Decision Date08/16/2019
Product Code DSR 
Docket Number 19M-3862
Notice Date 08/16/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT02627196
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 
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