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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 NumberS033
Date Received04/05/2024
Decision Date07/02/2024
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 legal manufacturer change, updates to the Directions for Use (DFU) labeling, and a transition to electronic DFU only with removal of the paper DFU with the packaged devices. The P990040/S033 submission requested to update the legal manufacturer to Cerenovus, Inc.; however, this ownership change was already made under the P990040/A015 submission and acknowledged in the FDA letter dated September 12, 2023, where the legal manufacturer and entity responsible for the PMA was modified from Medos International SARL to Cerenovus, Inc. You also verified by email on April 16, 2024, during the P990040/S033 review that no changes were made to the sites where manufacturing of the TRUFILL n-BCA Liquid Embolic System is performed due to the ownership change.
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