HDE supplement
H240004 S001: PHIL (Precipitating Hydrophobic Injectable Liquid) Liquid Embolic System
FDA HDE supplement · 30-day notice · MicroVention, Inc.
Key facts
| Original HDE | H240004 |
|---|---|
| Supplement number | S001 |
| Supplement type | 30-day notice |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | PHIL (Precipitating Hydrophobic Injectable Liquid) Liquid Embolic System |
| Generic name | Dural arteriovenous fistula liquid embolic |
| Applicant | MicroVention, Inc. |
| Product code | SGF |
| Received date | Apr 29, 2026 |
| Decision date | May 28, 2026 |
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: