Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
FDA premarket approval P220020/S007 · decided 2025-08-05
Approval details
- PMA number
- P220020
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Generic name
- Embolization Agent, Vascular
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2025-05-27
- Decision date
- 2025-08-05
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval for extending the shelf-life to three (3) years
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