PMA supplement
P180050 S009: Barostim System
FDA PMA supplement · Normal 180 Day Track · Cvrx, Inc.
Key facts
| Original PMA | P180050 |
|---|---|
| Supplement number | S009 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Barostim System |
| Generic name | Stimulator, carotid sinus nerve |
| Applicant | Cvrx, Inc. |
| Product code | DSR |
| Received date | Jun 7, 2023 |
| Decision date | Dec 22, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: