HDE supplement
H060003 S002: ONYX LIQUID EMBOLIC SYSTEM, ONYX HD-500 MODEL 105-8101-500
FDA HDE supplement · 30-day notice · EV3 INC
Key facts
| Original HDE | H060003 |
|---|---|
| Supplement number | S002 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | ONYX LIQUID EMBOLIC SYSTEM, ONYX HD-500 MODEL 105-8101-500 |
| Generic name | Polymerizing, neurovascular embolization material |
| Applicant | EV3 INC |
| Product code | OBA |
| Received date | Jul 16, 2013 |
| Decision date | Aug 14, 2013 |
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: