| 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. |
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| Device | BAROSTIM NEO® System |
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| Generic Name | Stimulator, carotid sinus nerve |
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| Regulation Number | 870.3850 |
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| Applicant | CVRx, INC.
9201 West Broadway Ave, Ste 650
Minneapolis, MN 55445 |
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| PMA Number | P180050 |
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| Date Received | 12/20/2018 |
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| Decision Date | 08/16/2019 |
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| Product Code |
DSR |
| Docket Number | 19M-3862 |
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| Notice Date | 08/16/2019 |
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| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT02627196
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 |
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