PMA
P220020: Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
FDA PMA · Embolization Agent, Vascular · Sirtex Medical, Inc.
Key facts
| PMA number | P220020 |
|---|---|
| Trade name | Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit |
| Generic name | Embolization Agent, Vascular |
| Applicant | Sirtex Medical, Inc. |
| Owner/operator | LamaMed Solutions Inc. |
| Product code | QVG |
| Approval date | Apr 4, 2023 |
| Docket number | 23M-1377 |
| Notice date | Apr 14, 2023 |
| Establishment registration | 3013476721 |
| FEI number | 3013476721 |
At a glance
- 1–9 Supplements
- Jul 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: