OrganOx metra® System
FDA premarket approval P200035/S028 · decided 2025-08-28
Approval details
- PMA number
- P200035
- Supplement
- S028
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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
- 2025-08-04
- Decision date
- 2025-08-28
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- adding caution and safety updates within the Instructions for Use (IFU) to enhance the safety of the OrganOx metra System.
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