HDE
H130007: BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL IN
FDA Humanitarian Device Exemption · CVRx, INC.
Key facts
| HDE number | H130007 |
|---|---|
| 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. |
| Owner/operator | CVRx, Inc. |
| Product code | DSR |
| Approval date | Dec 12, 2014 |
| Docket number | 14M-2247 |
| Notice date | Apr 17, 2015 |
| Establishment registration | 3007972010 |
| FEI number | 3007972010 |
At a glance
- 1–9 Supplements
- Jul 30, 2025 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 10–99 MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: