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Apollo Onyx Delivery Micro Catheter

by Ev3 Neurovascular PMA

Active United States

PMA P030004

Overview

The Apollo Onyx Delivery Micro Catheter is an injectable embolic agent delivery device designed for presurgical embolization of brain arteriovenous malformations. It is part of the ONYX LIQUID EMBOLIC SYSTEM and is used to deliver embolic material to target vascular lesions.

The device is supplied as a single-use catheter and requires appropriate storage conditions. It has received FDA PMA approval for the indicated use and is classified under product code MFE as a Class III device for injectable embolic agents.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP030004 Date21 Jul 2005ApprovedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Trade Name
Onyx Liquid Embolic System
Generic Name
Agent, injectable, embolic
PMA Number
FDA Product Code
MFE
Device Class
Class III
Advisory Committee
Neurology
FDA Decision
APPR Approved

Other devices from Ev3 Neurovascular

Questions

  • What is the Apollo Onyx Delivery Micro Catheter specifically designed to do in a clinical setting?

    The Apollo Onyx Delivery Micro Catheter is designed for presurgical embolization of brain arteriovenous malformations (AVMs). It is part of the ONYX Liquid Embolic System and is used to deliver embolic material directly to target vascular lesions in the brain before surgical intervention.

  • Is the Apollo Onyx Delivery Micro Catheter intended for single-use or repeated use?

    The Apollo Onyx Delivery Micro Catheter is explicitly supplied as a single-use device. This design ensures patient safety and sterility, as reuse could compromise the integrity of the catheter and introduce contamination risks.

  • What storage conditions should be followed for the Apollo Onyx Delivery Micro Catheter?

    While the exact storage conditions are not detailed in the provided data, the Apollo Onyx Delivery Micro Catheter is supplied as a single-use device, implying it should be stored according to standard medical device protocols—typically in a clean, dry environment, protected from extreme temperatures, and away from direct light until use.

  • How was the Apollo Onyx Delivery Micro Catheter approved by the FDA, and what does that mean for its use?

    The Apollo Onyx Delivery Micro Catheter received FDA approval through a Premarket Approval (PMA) application (PMA number: P030004), which is the highest level of regulatory review for medical devices. This approval confirms that the device has been determined safe and effective for its intended use—presurgical embolization of brain arteriovenous malformations—as outlined in the advisory committee’s decision.