Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
FDA premarket approval P220020/S005 · decided 2025-09-03
Approval details
- PMA number
- P220020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2025-03-17
- Decision date
- 2025-09-03
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval for a contract manufacturing site located in Wilmington, Massachusetts and to change the legal manufacturer address
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.