PMA
P030004: ONYX LIQUID EMBOLIC SYSTEM
FDA PMA · Agent, injectable, embolic · Ev3 Neurovascular
Key facts
| PMA number | P030004 |
|---|---|
| Trade name | ONYX LIQUID EMBOLIC SYSTEM |
| Generic name | Agent, injectable, embolic |
| Applicant | Ev3 Neurovascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MFE |
| Approval date | Jul 21, 2005 |
| Docket number | 05M-0328 |
| Notice date | Aug 22, 2005 |
| Establishment registration | 2029214 |
| FEI number | 1000220862 |
At a glance
- 10–99 Supplements
- Aug 5, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: