HDE supplement
H100004 S008: EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
FDA HDE supplement · special (immediate track) · Berlin Heart Inc.
Key facts
| Original HDE | H100004 |
|---|---|
| Supplement number | S008 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
| Generic name | Ventricular (assist) bypass |
| Applicant | Berlin Heart Inc. |
| Product code | DSQ |
| Received date | Dec 26, 2013 |
| Decision date | Mar 4, 2014 |
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: