Lava Liquid Embolic System (Lava LES)
FDA premarket approval P220020/S003 · decided 2024-09-24
Approval details
- PMA number
- P220020
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lava Liquid Embolic System (Lava LES)
- Generic name
- Embolization Agent, Vascular
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2024-08-28
- Decision date
- 2024-09-24
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- update the Mixing Manifold assembly process by adding an additional inspection step
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