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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceLava Liquid Embolic System (Lava LES) and Lava Mixing Kit
Generic NameEmbolization Agent, Vascular
ApplicantSirtex Medical, Inc.
300 Unicorn Park Dr., 2nd Floor ,
Woburn, MA 01801
PMA NumberP220020
Supplement NumberS007
Date Received05/27/2025
Decision Date08/05/2025
Product Code QVG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for extending the shelf-life to three (3) years
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