HDE
H070004: CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
FDA Humanitarian Device Exemption · Abbott
Key facts
| HDE number | H070004 |
|---|---|
| Trade name | CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
| Generic name | Right ventricular bypass (assist) device |
| Applicant | Abbott |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | OJE |
| Approval date | Oct 7, 2008 |
| Docket number | 08M0563 |
| Establishment registration | 2916596 |
| FEI number | 2916596 |
At a glance
- 10–99 Supplements
- Oct 2, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 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: