PMA P220020S007
- Device
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S007
- Product code
- QVG
- Decision date
- 2025-08-05
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- Approval for extending the shelf-life to three (3) years
Current openFDA PMA Record#
- Device
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S007
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2025-08-05
- Decision code
- APPR
- Date received
- 2025-05-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for extending the shelf-life to three (3) years