HDE
H060001: ENTERPRISE VASCULAR RECONSTRUCTIVE DEVICE AND DELIVERY SYSTEM
FDA Humanitarian Device Exemption · Medos International, SARL
Key facts
| HDE number | H060001 |
|---|---|
| Trade name | ENTERPRISE VASCULAR RECONSTRUCTIVE DEVICE AND DELIVERY SYSTEM |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Owner/operator | Medos International SARL |
| Product code | NJE |
| Approval date | May 8, 2007 |
| Docket number | 07M-0190 |
| Notice date | Sep 13, 2007 |
| Establishment registration | 3008114965 |
| FEI number | 3008114965 |
At a glance
- 10–99 Supplements
- Sep 25, 2024 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 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: