Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Basic Information
- Device Name
- Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
- Trade Name
- OrganOx metra System
- PMA Number
- P200035
- Device Class
- FDA Class 3
- Product Code
- QQK
- Generic Name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 9, 2021
- Date Received
- July 15, 2020
- Expedited Review
- N
- Docket Number
- 21M-1317
Advisory Committee Statement
Approval for the OrganOx metra System. The device is approved for the following indication: The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) <=40 years old, with <=20 mins of functional warm ischemic time (time from donor systolic blood pressure <50 mmHg), and macrosteatosis <=15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QQK | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation | FDA class 3 | Unknown |