HDE
H080005: ELANA ARTERIOTOMY SYSTEM
FDA Humanitarian Device Exemption · ELANA INC.
Key facts
| HDE number | H080005 |
|---|---|
| Trade name | ELANA ARTERIOTOMY SYSTEM |
| Generic name | Surgical kit |
| Applicant | ELANA INC. |
| Product code | PAX |
| Approval date | Mar 10, 2011 |
| Docket number | 11M0170 |
At a glance
- 1–9 Supplements
- Aug 15, 2016 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- None 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: