- Device
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S005
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2025-09-03
- Decision code
- APPR
- Date received
- 2025-03-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a contract manufacturing site located in Wilmington, Massachusetts and to change the legal manufacturer address