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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NamePHIL Liquid Embolic System
Classification Namedural arteriovenous fistula liquid embolic
Generic Namedural arteriovenous fistula liquid embolic
Applicant
MicroVention, Inc.
35 enterprise
aliso veijo, CA 92656
HDE NumberH240004
Date Received10/22/2024
Decision Date12/31/2025
Product Code
SGF
Docket Number FDA-0463
Notice Date 11/16/2026
Advisory Committee Neurology
Clinical Trials NCT03467542
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The phil liquid embolic system is indicated for use in the treatment of intracranial dural arteriovenous fistulas (davfs).
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Labeling Part 2
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