LAVA® Liquid Embolic System (LAVA LES)
FDA premarket approval P220020/S001 · decided 2023-10-26
Approval details
- PMA number
- P220020
- Supplement
- S001
- Supplement type
- 30-Day Notice
- 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
- 2023-09-26
- Decision date
- 2023-10-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- an alternate location for the testing facility for bioburden and endotoxin testing
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