PMA supplement
P180050 S011: BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si
FDA PMA supplement · Special (Immediate Track) · Cvrx, Inc.
Key facts
| Original PMA | P180050 |
|---|---|
| Supplement number | S011 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BAROSTIM NEO Implantable Pulse Generator (IPG), BAROSTIM NEO Carotid Sinus Lead (CSL) Kit, Programmer System, Carotid Si |
| Generic name | Stimulator, carotid sinus nerve |
| Applicant | Cvrx, Inc. |
| Product code | DSR |
| Received date | Nov 9, 2023 |
| Decision date | Apr 19, 2024 |
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: