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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NamePHIL (Precipitating Hydrophobic Injectable Liquid) Liquid Embolic System
Classification Namedural arteriovenous fistula liquid embolic
Generic Namedural arteriovenous fistula liquid embolic
Applicant
MicroVention, Inc.
35 enterprise
aliso viejo, CA 92656
HDE NumberH240004
Supplement NumberS001
Date Received04/29/2026
Decision Date05/28/2026
Product Code
SGF[ Registered Establishments with SGF ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of manufacturing changes to transition to a new resin formulation for the universal adaptor used in the delivery of the phil (precipitating hydrophobic injectable liquid) liquid embolic system and to modify manufacturing flow of a raw material based on test results and qualification of an additional supplier.
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