HDE supplement
H030003 S001: DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM
FDA HDE supplement · normal 75 day track · RELIANTHEART INC.
Key facts
| Original HDE | H030003 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | other |
| Trade name | DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM |
| Applicant | RELIANTHEART INC. |
| Received date | Jun 7, 2004 |
| Decision date | Dec 8, 2004 |
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: