OrganOx metra System
FDA premarket approval P200035 · decided 2021-12-09
Approval details
- PMA number
- P200035
- Trade name
- OrganOx metra System
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Applicant
- Organox Limited
- Date received
- 2020-07-15
- Decision date
- 2021-12-09
- Days to decision
- 512 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- 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
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