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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSQUID Liquid Embolic Agent (LEA)
Generic NameNeurovascular Liquid Embolic Agent
ApplicantBalt USA, LLC
29 Parker
Irvine, CA 92618
PMA NumberP250009
Date Received03/21/2025
Decision Date01/30/2026
Product Code SGU 
Docket Number FDA-1387
Notice Date 02/10/2026
Advisory Committee Neurology
Clinical TrialsNCT04410146
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The SQUID Liquid Embolic Agent is indicated for the embolization of the middle meningeal artery (MMA) as an adjunct to usual care treatment in patients with symptomatic chronic subdural hematoma(s) (SDH) measuring 10 mm or greater in thickness in whom an intervention is deemed necessary as determined by a neurosurgeon.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 
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