HDE supplement
H100004 S020: EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
FDA HDE supplement · normal 75 day track · Berlin Heart Inc.
Key facts
| Original HDE | H100004 |
|---|---|
| Supplement number | S020 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
| Generic name | Pediatric ventricular assist device |
| Applicant | Berlin Heart Inc. |
| Product code | PCK |
| Received date | Jul 27, 2016 |
| Decision date | Oct 12, 2016 |
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: