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FDA PMA

Iliac covered stent, arterial

PMA Number: P120003 · 2026-05-13

ApplicantAtrium Medical Corp.
Decision Date2026-05-13
PMA NumberP120003
Product CodePRL
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Iliac covered stent, arterial is a medical device manufactured by Atrium Medical Corp.. It received FDA Premarket Approval (PMA) on 2026-05-13 under PMA number P120003. The device is classified under FDA product code PRL. It was reviewed by the CV 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 the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. 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 Iliac covered stent, arterial?

Iliac covered stent, arterial is a medical device that received FDA Premarket Approval (PMA) on 2026-05-13. It is manufactured by Atrium Medical Corp.. The PMA number is P120003.

When did Iliac covered stent, arterial receive FDA PMA approval?

Iliac covered stent, arterial received FDA PMA approval on 2026-05-13, under approval number P120003.

What company makes Iliac covered stent, arterial?

Iliac covered stent, arterial is manufactured by Atrium Medical Corp..

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 the manufacturer to provide clinical data proving safety and effectiveness. PMA is the most stringent type of device marketing application required by the FDA.

What is the FDA product code for Iliac covered stent, arterial?

The FDA product code for Iliac covered stent, arterial is PRL.

What FDA device class is Iliac covered stent, arterial?

Iliac covered stent, arterial is classified as Class III by the FDA.

Official Source

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

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