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 System |
| Generic Name | Stimulator, Carotid Sinus Nerve |
| Applicant | CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS005 Date Received03/28/2022 Decision Date04/26/2022 Product Code DSR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-04-26 |
| PMA | P180050 |
| Supplement | S005 |
| Product Code | DSR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CVRx, INC. 9201 West Broadway Ave, Ste 650 minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS005 Date Received03/28/2022 Decision Date04/26/2022 Product Code DSR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Reduction In The Amount Of Ethylene Oxide And An Increase In The Load Capacity For The Sterilization Process |
| 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 |