PMA P990040S038

Device: TRUFILL n-BCA Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S038
Product code: KGG
Decision date: 2026-05-26
Classification: Neurology
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Approval order statement: approval for implementation of alternate dry heat sterilization cycle parameters in a dedicated batch oven for TRUFILL n-BCA Liquid Embolization component manufactured and sterilized at Chemence Medical, Inc

Current openFDA PMA Record#

Device: TRUFILL n-BCA Liquid Embolic System
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S038
Product code: KGG
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date: 2026-05-26
Decision code: OK30
Date received: 2026-04-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for implementation of alternate dry heat sterilization cycle parameters in a dedicated batch oven for TRUFILL n-BCA Liquid Embolization component manufactured and sterilized at Chemence Medical, Inc