HDE
H030003: DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
FDA Humanitarian Device Exemption · RELIANTHEART INC.
Key facts
| HDE number | H030003 |
|---|---|
| Trade name | DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM |
| Generic name | Ventricular (assist) bypass |
| Applicant | RELIANTHEART INC. |
| Product code | DSQ |
| Approval date | Feb 25, 2004 |
| Docket number | 04M-0090 |
At a glance
- 10–99 Supplements
- Oct 1, 2010 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None 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: