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FDA PMA

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation

PMA Number: P160013 · 2026-05-13

ApplicantTransMedics, Inc.
Decision Date2026-05-13
PMA NumberP160013
Product CodeQBA
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is the device name listed in this FDA 510(k) record. The listed applicant is TransMedics, Inc.. It received FDA 510(k) clearance on 2026-05-13. The device is classified under product code QBA. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?

Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is a medical device that received FDA 510(k) clearance on 2026-05-13. The listed applicant is TransMedics, Inc..

When did Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation receive FDA 510(k) clearance?

The clearance date for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation can be found in the official FDA records.

Who is the listed applicant for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?

The FDA 510(k) record lists TransMedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation?

The FDA product code for Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation is QBA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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