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U.S. Department of Health and Human Services

Product Classification

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Device normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation
Definition To preserve donor lungs prior to transplantation
Physical State The device may consists of a portable enclosure with electronics and hardcore that control the ventilation and perfusion of the donor organ, disposable components that complete the ventilation and perfusion circuits, and a preservation solution used to perfuse the organ.
Technical Method The device perfuses and ventilates the donor lungs prior to transplantation
Target Area Donor lungs
Review Panel Gastroenterology/Urology
Product CodeQBA
Premarket Review GastroRenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible