TransMedics Group Gets FDA 510(k) Clearance for OCS Lung Solution

August 2, 2021

Organ transplant therapy company TransMedics Group has received FDA 510(k) clearance for its OCS Lung Solution for use in transplants using cold-storage techniques.

The colorless, sterile, low-potassium solution is cleared for hypothermic flushing, storage and transportation of donor lungs for transplantation.

The OCS Lung Solution, which is a component of the company's OCS Lung System, has a 24-month shelf life.

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