Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Lava Liquid Embolic System (Lava LES)
• Generic Name: Embolization Agent, Vascular
• Applicant: Sirtex Medical, Inc.; 300 Unicorn Park Dr., 2nd Floor ,; Woburn, MA 01801
• PMA Number: P220020
• Supplement Number: S003
• Date Received: 08/28/2024
• Decision Date: 09/24/2024
• Product Code: QVG
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
update the Mixing Manifold assembly process by adding an additional inspection step