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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.
 
DeviceTRUFILL n-BCA Liquid Embolic System
Generic Nametissue adhesive for use in embolization of brain arteriovenous malformations
ApplicantCerenovus, Inc.
6303 Waterford District Dr.
Suite 315
Miami, FL 33126
PMA NumberP990040
Supplement NumberS038
Date Received04/21/2026
Decision Date05/26/2026
Product Code KGG 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for implementation of alternate dry heat sterilization cycle parameters in a dedicated batch oven for TRUFILL n-BCA Liquid Embolization component manufactured and sterilized at Chemence Medical, Inc
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