Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
PMA P220020
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP220020 | Date4 Apr 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Embolization Agent, Vascular
- PMA Number
- FDA Product Code
- QVG
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Lava Liquid Embolic System (Lava LES) is a Vascular Embolization Agent (generic name) designed for the occlusion of arterial blood flow in peripheral vasculature. It is a liquid embolic agent intended to selectively block abnormal blood vessels, thereby treating arterial hemorrhage through embolization procedures. The system is classified as a Class III medical device under FDA regulations, requiring premarket approval (PMA).
The Lava LES is supplied as a liquid embolic agent paired with a Lava Mixing Kit, which facilitates preparation and administration. It is intended for single-use and must be handled under sterile conditions in an interventional radiology or vascular surgery setting. The device is not MRI-safe and requires proper storage as per manufacturer instructions. Approval for this system was granted under FDA_PMA (P220020) for embolization of arterial hemorrhage in peripheral vasculature.
Other devices from Sirtex Medical, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the Lava Liquid Embolic System (Lava LES) primarily used for in clinical practice?
The Lava LES is specifically designed for embolization procedures to selectively block abnormal blood vessels in the peripheral vasculature, helping to treat arterial hemorrhage. It works by occluding arterial blood flow, which is critical in interventional radiology or vascular surgery settings where controlling bleeding is essential.
How is the Lava Liquid Embolic System supplied, and what role does the Lava Mixing Kit play?
The Lava LES is supplied as a liquid embolic agent paired with the **Lava Mixing Kit**, which is essential for preparing and administering the device. The kit ensures proper handling and mixing of the embolic material before use, maintaining sterility and usability in controlled procedural environments.
Is the Lava Liquid Embolic System intended for single-use or repeated use, and how should it be stored?
The Lava LES is designed for **single-use only** and must be handled under sterile conditions. Storage instructions are provided by the manufacturer, though the device is **not MRI-safe**, so proper storage away from magnetic fields is required to preserve its integrity.
What regulatory pathway was followed for the approval of the Lava Liquid Embolic System?
The Lava LES underwent **FDA Premarket Approval (PMA)** under the designation **P220020**, reflecting its classification as a **Class III medical device**. This rigorous approval process ensures its safety and effectiveness for embolization of arterial hemorrhage in peripheral vasculature, as outlined in the **FDA_PMA authorization**.
Can the Lava Liquid Embolic System be used in any imaging modality, or are there restrictions?
The Lava LES is **not MRI-safe**, meaning it should not be used in magnetic resonance imaging environments. Clinicians must verify compatibility with the planned imaging modality before and during procedures to avoid potential risks or interference.