HDE
H060003: ONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL 105-8101-500
FDA Humanitarian Device Exemption · EV3 INC
Key facts
| HDE number | H060003 |
|---|---|
| Trade name | ONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL 105-8101-500 |
| Generic name | Polymerizing, neurovascular embolization material |
| Applicant | EV3 INC |
| Owner/operator | Medtronic, Inc. |
| Product code | OBA |
| Approval date | Apr 11, 2007 |
| Docket number | 07M-1056 |
| Establishment registration | 2183870 |
| FEI number | 2183870 |
At a glance
- 1–9 Supplements
- Oct 9, 2013 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- 10–99 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: