HDE supplement
H030003 S010: MICROMED HEART ASSIST 5 PEDIATRIC VAD LEFT VENTRICULAR ASSIST DEVICE
FDA HDE supplement · normal 75 day track · RELIANTHEART INC.
Key facts
| Original HDE | H030003 |
|---|---|
| Supplement number | S010 |
| Supplement type | normal 75 day track |
| Reason for the supplement | other |
| Trade name | MICROMED HEART ASSIST 5 PEDIATRIC VAD LEFT VENTRICULAR ASSIST DEVICE |
| Generic name | Ventricular (assist) bypass |
| Applicant | RELIANTHEART INC. |
| Product code | DSQ |
| Received date | May 26, 2010 |
| Decision date | Oct 1, 2010 |
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: