PMA P990040S034

Device: TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S034
Product code: SGU
Decision date: 2025-12-16
Classification: Neurology
Generic name: Neurovascular Liquid Embolic Agent
Approval order statement: The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired and for embolization of the Middle Meningeal Artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (SDH) as an adjunct to surgery.

Current openFDA PMA Record#

Device: TRUFILL n-BCA Liquid Embolic System (LES), TRUFILL n-BCA Liquid Embolic System Procedural Set
Applicant: Cerenovus, Inc.
PMA number: P990040
Supplement: S034
Product code: SGU
Generic name: Neurovascular Liquid Embolic Agent
Decision date: 2025-12-16
Decision code: APPR
Date received: 2025-02-03
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired and for embolization of the Middle Meningeal Artery (MMA) for the treatment of symptomatic subacute and chronic Subdural Hematoma (SDH) as an adjunct to surgery.