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FDA PMA

Agent, injectable, embolic

PMA Number: P030004 · 2026-08-05

ApplicantEv3 Neurovascular
Decision Date2026-08-05
PMA NumberP030004
Product CodeMFE
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeNE

Device Summary

Agent, injectable, embolic is the device name listed in this FDA PMA record. The listed applicant is Ev3 Neurovascular. It received FDA Premarket Approval (PMA) on 2026-08-05 under PMA number P030004. The device is classified under FDA product code MFE. It was reviewed by the NE advisory panel. This device is classified as Class III by the FDA. Class III devices subject to the most stringent regulatory controls. These devices generally require premarket approval (PMA) because they support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of U. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.

Frequently Asked Questions

What is Agent, injectable, embolic?

Agent, injectable, embolic is a medical device that received FDA Premarket Approval (PMA) on 2026-08-05. The listed applicant is Ev3 Neurovascular. The PMA number is P030004.

When did Agent, injectable, embolic receive FDA PMA approval?

Agent, injectable, embolic received FDA PMA approval on 2026-08-05, under PMA number P030004.

Who is the listed applicant for Agent, injectable, embolic?

The FDA PMA record lists Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the difference between PMA and 510(k)?

PMA (Premarket Approval) is the FDA process for evaluating Class III medical devices. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires valid scientific evidence providing reasonable assurance of safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Agent, injectable, embolic?

The FDA product code for Agent, injectable, embolic is MFE.

What FDA device class is Agent, injectable, embolic?

Agent, injectable, embolic is classified as Class III by the FDA.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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