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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.
 
DeviceSQUID Liquid Embolic Agent (LEA)
Generic NameNeurovascular Liquid Embolic Agent
ApplicantBalt USA, LLC
29 Parker
Irvine, CA 92618
PMA NumberP250009
Supplement NumberS002
Date Received06/15/2026
Decision Date09/09/2026
Product Code SGU 
Advisory Committee Neurology
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 changes to the mixing time for the SQUID Liquid Embolic Agent (LEA).
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