| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007972010 | 3007972010 | CVRX, INC. | 1 | N | 2026-01-01 | 9201 W Broadway Ave Ste 650 Minneapolis MN US 55445 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859144004432 | BAROSTIM NEO - BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial) | 7634167457 | acrouse@cvrx.com |
| 00859144004449 | BAROSTIM Programmer - Model 9010 Programmer System (US Commercial) | 7634167457 | acrouse@cvrx.com |
| 00859144004470 | BAROSTIM NEO - BAROSTIM NEO Model 1037 Carotid Sinus Lead Kit | 7634167457 | acrouse@cvrx.com |
| 00859144004623 | Barostim NEO2 - Model 2104 Barostim NEO2 Implantable Pulse Generator | 763-416-7457 | acrouse@cvrx.com |
| 00859144004630 | Barostim - Model 9020 Barostim Programmer System | 763-416-7457 | acrouse@cvrx.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 125333 | 1344007448 | P180050 | BAROSTIM NEO® System | DSR | 2019-08-16 |
| 125333 | 1487140494 | H130007 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DSR | 1 | 2019-08-16 |
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 D...
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS007 Date Received05/31/2022 Decision Date06/27/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 D...
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS006 Date Received05/20/2022 Decision Date06/14/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 D...
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...
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS002 Date Received09/20/2021 Decision Date04/14/2022 Product Code DSR Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason ...
CVRx, INC.9201 West Broadway Ave, Ste 650minneapolis, MN 55445 PMA NumberP180050 Supplement NumberS004 Date Received03/17/2022 Decision Date04/12/2022 Product Code DSR Advisory Committee Cardiovascular Clinical TrialsNCT02627196 Supplement Typenormal 180 D...
CVRx, INC.
CVRx, INC.
2026-01-21
2026-01-21
2019-08-22
2019-08-22
2015-01-21
2015-01-21
2015-01-21
2019-08-22
2019-08-22
2019-08-22
2015-01-21
2015-01-21
cvrx.com