HDE supplement
H130007 S007: BAROSTIM Legacy Implantable Pulse Generator (IPG);Rheos Carotid Sinus Lead (CSL); Programmer System;Carotid Sinus Lead (
FDA HDE supplement · normal 75 day track · Cvrx, Inc.
Key facts
| Original HDE | H130007 |
|---|---|
| Supplement number | S007 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | BAROSTIM Legacy Implantable Pulse Generator (IPG);Rheos Carotid Sinus Lead (CSL); Programmer System;Carotid Sinus Lead ( |
| Generic name | Stimulator, carotid sinus nerve |
| Applicant | Cvrx, Inc. |
| Product code | DSR |
| Received date | May 22, 2025 |
| Decision date | Jul 30, 2025 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: