HDE supplement
H100008 S001: TRIVASCULAR INC OVATION ABDOMINAL STENT SYSTEM
FDA HDE supplement · normal 75 day track · TRIVASCULAR INC
Key facts
| Original HDE | H100008 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | TRIVASCULAR INC OVATION ABDOMINAL STENT SYSTEM |
| Generic name | System, endovascular graft, aortic aneurysm treatment |
| Applicant | TRIVASCULAR INC |
| Product code | MIH |
| Received date | Dec 12, 2011 |
| Decision date | Apr 13, 2012 |
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: