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TruFill N-Butyl Cyanoacrylate Liquid Embolic System

FDA PMA

Class III (US FDA PMA)

PMA P990040

by Cerenovus, Inc.

Identity

Trade Name
TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEM FDA PMA
Generic Name
tissue adhesive for use in embolization of brain arteriovenous malformations FDA PMA

Identifiers

PMA Number
P990040 FDA PMA
FDA Product Code
KGG FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Neurology FDA PMA
FDA Decision
APPR Approved FDA PMA

The TruFill N-Butyl Cyanoacrylate Liquid Embolic System is a tissue adhesive classified as a Class III medical device for embolization. It is designed to occlude cerebral arteriovenous malformations (AVMs) during presurgical devascularization, providing a liquid embolic agent to seal abnormal blood vessels and reduce vascular flow.

This system is supplied as a sterile, single-use device and is intended for use in interventional radiology or neurosurgery settings. It is regulated under an FDA Premarket Approval (PMA) with the designation P990040, adhering to strict manufacturing and performance standards. The device is packaged for immediate clinical use and must be stored according to manufacturer instructions to maintain sterility and efficacy.

Frequently asked questions

What clinical procedure is the TruFill N-Butyl Cyanoacrylate Liquid Embolic System specifically intended to support during presurgical planning?

The TruFill N-Butyl Cyanoacrylate Liquid Embolic System is designed for embolization of cerebral arteriovenous malformations (AVMs) during presurgical devascularization. It acts as a liquid embolic agent to seal abnormal blood vessels, reducing blood flow to the AVM before surgery to minimize complications.

Is the TruFill N-Butyl Cyanoacrylate Liquid Embolic System reusable, or is it meant for single-use only?

The TruFill N-Butyl Cyanoacrylate Liquid Embolic System is explicitly supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining the integrity of the embolic material for one procedure only.

How should the TruFill N-Butyl Cyanoacrylate Liquid Embolic System be stored to preserve its sterility and performance?

The device must be stored according to the manufacturer’s instructions to maintain sterility and efficacy. Since it is a sterile, single-use system, it is packaged for immediate clinical use, so proper storage conditions (e.g., dry, protected from light, and within expiration dates) are critical to avoid degradation before use.

What regulatory pathway does the TruFill N-Butyl Cyanoacrylate Liquid Embolic System follow, and what does that mean for its use?

The TruFill N-Butyl Cyanoacrylate Liquid Embolic System is regulated under an FDA Premarket Approval (PMA) with the designation **P990040**, meaning it has undergone rigorous review to demonstrate safety and effectiveness for its intended use in embolizing cerebral AVMs during presurgical devascularization. This approval ensures compliance with strict manufacturing and performance standards.

What types of medical specialties or settings would typically use the TruFill N-Butyl Cyanoacrylate Liquid Embolic System?

This system is intended for use in **interventional radiology** or **neurosurgery** settings, where specialists like interventional neuroradiologists or vascular surgeons perform embolization procedures. The advisory committee designation for this device is **Neurology**, reflecting its primary application in treating cerebral AVMs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA PMA P990040 24 fields · synced Sep 18, 2026