PMA P220020S003
- Device
- Lava Liquid Embolic System (Lava LES)
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S003
- Product code
- QVG
- Decision date
- 2024-09-24
- Classification
- Cardiovascular
- Generic name
- Embolization Agent, Vascular
- Approval order statement
- update the Mixing Manifold assembly process by adding an additional inspection step
Current openFDA PMA Record#
- Device
- Lava Liquid Embolic System (Lava LES)
- Applicant
- Sirtex Medical, Inc.
- PMA number
- P220020
- Supplement
- S003
- Product code
- QVG
- Generic name
- Embolization Agent, Vascular
- Decision date
- 2024-09-24
- Decision code
- APPR
- Date received
- 2024-08-28
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- update the Mixing Manifold assembly process by adding an additional inspection step