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FDA PMA

Stent, carotid

PMA Number: P240009 · 2026-05-08

ApplicantContego Medical, Inc.
Decision Date2026-05-08
PMA NumberP240009
Product CodeNIM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCV

Device Summary

Stent, carotid is a medical device manufactured by Contego Medical, Inc.. It received FDA Premarket Approval (PMA) on 2026-05-08 under PMA number P240009. The device is classified under FDA product code NIM. 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 Stent, carotid?

Stent, carotid is a medical device that received FDA Premarket Approval (PMA) on 2026-05-08. It is manufactured by Contego Medical, Inc.. The PMA number is P240009.

When did Stent, carotid receive FDA PMA approval?

Stent, carotid received FDA PMA approval on 2026-05-08, under approval number P240009.

What company makes Stent, carotid?

Stent, carotid is manufactured by Contego Medical, Inc..

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 Stent, carotid?

The FDA product code for Stent, carotid is NIM.

What FDA device class is Stent, carotid?

Stent, carotid 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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