This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval to add an alternate implantable pulse generator model 2104 and associated model 9010 programmer system software.
| Device | Barostim NEO System, Barostim NEO2 System |
| Generic Name | Stimulator, Carotid Sinus Nerve |
| Applicant | CVRx, INC. |
| Date Received | 2021-01-19 |
| Decision Date | 2021-12-17 |
| PMA | P180050 |
| Supplement | S001 |
| Product Code | DSR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |