PMA
P250009: SQUID Liquid Embolic Agent (LEA)
FDA PMA · Neurovascular Liquid Embolic Agent · Balt USA, LLC
Key facts
| PMA number | P250009 |
|---|---|
| Trade name | SQUID Liquid Embolic Agent (LEA) |
| Generic name | Neurovascular Liquid Embolic Agent |
| Applicant | Balt USA, LLC |
| Owner/operator | Balt USA, LLC |
| Product code | SGU |
| Approval date | Jan 30, 2026 |
| Docket number | FDA-1387 |
| Notice date | Feb 10, 2026 |
| Establishment registration | 3014162263 |
| FEI number | 3014162263 |
At a glance
- 1–9 Supplements
- Sep 9, 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- No Withdrawn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: