Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set
Generic NameNeurovascular Liquid Embolic Agent
ApplicantCerenovus, Inc.
6303 Waterford District Dr.
Suite 315
Miami, FL 33126
PMA NumberP990040
Supplement NumberS034
Date Received02/03/2025
Decision Date12/16/2025
Product Codes KGG SGU 
Advisory Committee Neurology
Clinical TrialsNCT04816591
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired and for embolization of the Middle Meningeal Artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (SDH) as an adjunct to surgery.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-