Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
FDA premarket approval P220020/S004 · decided 2025-03-20
Approval details
- PMA number
- P220020
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Generic name
- Embolization Agent, Vascular
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2025-02-18
- Decision date
- 2025-03-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- a change to acceptance criteria for air and liquid leak testing of the mixing manifold
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.