Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
FDA premarket approval P220020 · decided 2023-04-04
Approval details
- PMA number
- P220020
- Trade name
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Generic name
- Embolization Agent, Vascular
- Applicant
- Sirtex Medical, Inc.
- Date received
- 2022-10-06
- Decision date
- 2023-04-04
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- QVG
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- Approval for the Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit. The device is indicated for embolization of arterial hemorrhage in the peripheral vasculature.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.