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Device | TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System |
Generic Name | tissue adhesive for use in embolization of brain arteriovenous malformations |
Applicant | Cerenovus, Inc. 6303 Waterford District Drive, Suite 315 Miami, FL 33126 |
PMA Number | P990040 |
Supplement Number | S031 |
Date Received | 11/30/2022 |
Decision Date | 09/29/2023 |
Product Code |
KGG |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |