PMA P990040S031

Device: TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S031
Product code: KGG
Decision date: 2023-09-29
Classification: Neurology
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
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.

Current openFDA PMA Record#

Device: TRUFILL™ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S031
Product code: KGG
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date: 2023-09-29
Decision code: APPR
Date received: 2022-11-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.