PMA P990040S032

Device: TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S032
Product code: KGG
Decision date: 2024-02-13
Classification: Neurology
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Approval order statement: approval to implement a modified sample preparation for routine bacterial endotoxin testing of the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System Procedural Set

Current openFDA PMA Record#

Device: TRUFILL n-BCA Liquid Embolic System (LES) Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S032
Product code: KGG
Generic name: tissue adhesive for use in embolization of brain arteriovenous malformations
Decision date: 2024-02-13
Decision code: OK30
Date received: 2024-01-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to implement a modified sample preparation for routine bacterial endotoxin testing of the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System Procedural Set