HDE
H040006: ABIOCOR IMPLANTABLE REPLACEMENT HEART
FDA Humanitarian Device Exemption · ABIOMED, INC.
Key facts
| HDE number | H040006 |
|---|---|
| Trade name | ABIOCOR IMPLANTABLE REPLACEMENT HEART |
| Generic name | Artificial heart |
| Applicant | ABIOMED, INC. |
| Owner/operator | ABIOMED, INC. |
| Product code | LOZ |
| Approval date | Sep 5, 2006 |
| Docket number | 06M-0368 |
| Establishment registration | 1220648 |
| FEI number | 1220648 |
At a glance
- 1–9 Supplements
- Jan 17, 2008 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- 1–9 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: