HDE supplement
H130007 S001: BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL IN
FDA HDE supplement · normal 75 day track · CVRx, INC.
Key facts
| Original HDE | H130007 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL IN |
| Generic name | Stimulator, carotid sinus nerve |
| Applicant | CVRx, INC. |
| Product code | DSR |
| Received date | Jun 14, 2016 |
| Decision date | Jul 8, 2016 |
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: