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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)
Generic NameEmbolization Agent, Vascular
ApplicantSirtex Medical, Inc.
300 Unicorn Park Dr., 2nd Floor ,
Woburn, MA 01801
PMA NumberP220020
Supplement NumberS008
Date Received06/12/2026
Decision Date07/09/2026
Product Code QVG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of the Automated Viscometer for LAVA LES kinematic viscosity testing
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