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 Code | QBA |
Premarket Review |
Office of 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? |
No
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |