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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-Butyl Cyanoacrylate (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 NumberS031
Date Received11/30/2022
Decision Date09/29/2023
Product Code KGG 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
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 a new packaging configuration of the TRUFILL n-BCA Liquid Embolic System that includes the device co-packaged with the procedural accessories used in the preparation of the liquid embolic in a new packaging tray, sterilized with an additional ethylene oxide (EO) sterilization cycle, and provided with electronic Instructions for Use and a Quick Start Guide.
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