HDE
H100004: EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE
FDA Humanitarian Device Exemption · Berlin Heart Inc.
Key facts
| HDE number | H100004 |
|---|---|
| Trade name | EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
| Generic name | Pediatric ventricular assist device |
| Applicant | Berlin Heart Inc. |
| Owner/operator | Berlin Heart GmbH |
| Product code | PCK |
| Approval date | Dec 16, 2011 |
| Docket number | 11M0919 |
| Establishment registration | 3004582654 |
| FEI number | 3004582654 |
At a glance
- 10–99 Supplements
- Feb 27, 2017 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 100–999 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: