PMA P990040S035

Device: TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S035
Product code: KGG
Decision date: 2025-05-28
Classification: Neurology
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Approval order statement: approval for the temporary relocation of equipment and manufacturing operations from one cleanroom (ISO Class 8) to another cleanroom (ISO Class 8) within the same building

Current openFDA PMA Record#

Device: TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S035
Product code: KGG
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date: 2025-05-28
Decision code: OK30
Date received: 2025-05-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the temporary relocation of equipment and manufacturing operations from one cleanroom (ISO Class 8) to another cleanroom (ISO Class 8) within the same building