OrganOx metra System
FDA premarket approval P200035/S022 · decided 2025-06-10
Approval details
- PMA number
- P200035
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 2025-03-14
- Decision date
- 2025-06-10
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- replacement of the stepper motor to the Haydon 4300 Series stepper motor within the OrganOx metra Retained Unit (D0003) due to obsolescence of the prior stepper motor
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