HDE supplement
H060001 S007: CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA HDE supplement · special (immediate track) · Medos International, SARL
Key facts
| Original HDE | H060001 |
|---|---|
| Supplement number | S007 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM |
| Generic name | Intracranial neurovascular stent |
| Applicant | Medos International, SARL |
| Product code | NJE |
| Received date | Apr 2, 2008 |
| Decision date | May 2, 2008 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: