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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
ApplicantBlackSwan Vascular, Inc.
709 Sandoval Way
Hayward, CA 94544
PMA NumberP220020
Supplement NumberS002
Date Received10/12/2023
Decision Date11/07/2023
Product Code QVG 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval of an alternate location for the bioburden and endotoxin testing facility
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