The barostim neo system 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.
| Device | BAROSTIM NEO® System |
| Classification Name | Stimulator, Carotid Sinus Nerve |
| Generic Name | Stimulator, Carotid Sinus Nerve |
| Applicant | CVRx, INC. |
| Date Received | 2018-12-20 |
| Decision Date | 2019-08-16 |
| PMA | P180050 |
| Supplement | S |
| Product Code | DSR |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CVRx, INC. 9201 West Broadway Ave, Ste 650 minneapolis, MN 55445 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180050 | Original Filing | |
| S008 | 2022-12-23 | Normal 180 Day Track No User Fee |
| S007 | 2022-05-31 | Normal 180 Day Track No User Fee |
| S006 | 2022-05-20 | Normal 180 Day Track No User Fee |
| S005 | 2022-03-28 | 30-day Notice |
| S004 | 2022-03-17 | Normal 180 Day Track No User Fee |
| S003 | ||
| S002 | 2021-09-20 | Normal 180 Day Track |
| S001 | 2021-01-19 | Normal 180 Day Track |