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.
| Device | BAROSTIM NEO® System |
| Generic Name | Stimulator, Carotid Sinus Nerve |
| Applicant | CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS008 Date Received12/23/2022 Decision Date01/20/2023 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-12-23 |
| Decision Date | 2023-01-20 |
| PMA | P180050 |
| Supplement | S008 |
| Product Code | DSR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CVRx, INC. 9201 West Broadway Ave, Ste 650 minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS008 Date Received12/23/2022 Decision Date01/20/2023 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Protocol For The Post-approval Study Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P180050. |
| 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 |