PMA
P180050: BAROSTIM NEO® System
FDA PMA · Stimulator, carotid sinus nerve · Cvrx, Inc.
Key facts
| PMA number | P180050 |
|---|---|
| Trade name | BAROSTIM NEO® System |
| Generic name | Stimulator, carotid sinus nerve |
| Applicant | Cvrx, Inc. |
| Owner/operator | CVRx, Inc. |
| Product code | DSR |
| Approval date | Aug 16, 2019 |
| Docket number | 19M-3862 |
| Notice date | Aug 16, 2019 |
| Establishment registration | 3007972010 |
| FEI number | 3007972010 |
At a glance
- 10–99 Supplements
- Jul 11, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: