PMA supplement
P030004 S035: Onyx Liquid Embolic System (LES)
FDA PMA supplement · Panel Track · Ev3 Neurovascular
Key facts
| Original PMA | P030004 |
|---|---|
| Supplement number | S035 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Onyx Liquid Embolic System (LES) |
| Generic name | Neurovascular Liquid Embolic Agent |
| Applicant | Ev3 Neurovascular |
| Product code | SGU |
| Received date | Oct 15, 2024 |
| Decision date | Dec 8, 2025 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: