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U.S. Department of Health and Human Services

Product Classification

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Device normothermic preservation system for transplantation of initially unacceptable donor lungs
Definition Preservation of donor lungs for transplantation.
Physical State Device consists of a system made up of several components, such as an oxygenator, ventilator, thermal control unit, flow pumps, as well as dedicated disposable sets, cannulation accessories, organ chamber and preservation solution.
Technical Method Device actively perfuses the donor lung with a preservation solution, while also ventilating and oxygenating it, and while maintaining it in near-physiologic temperatures, so that it may be preserved and assessed for transplantation.
Target Area Donor lungs
Review Panel Gastroenterology/Urology
Product CodePHO
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
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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