PMA P220020S004
- Device
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S004
- Product code
- QVG
- Decision date
- 2025-03-20
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- a change to acceptance criteria for air and liquid leak testing of the mixing manifold
Current openFDA PMA Record#
- Device
- Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S004
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2025-03-20
- Decision code
- OK30
- Date received
- 2025-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to acceptance criteria for air and liquid leak testing of the mixing manifold