HDE supplement
H210004 S002: NeVa VS
FDA HDE supplement · normal 75 day track · Vesalio
Key facts
| Original HDE | H210004 |
|---|---|
| Supplement number | S002 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | NeVa VS |
| Generic name | Temporary percutaneous transluminal cerebral artery dilatation device |
| Applicant | Vesalio |
| Product code | QTK |
| Received date | Feb 25, 2025 |
| Decision date | Mar 11, 2025 |
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: