OrganOx metra System
FDA premarket approval P200035/S018 · decided 2025-04-16
Approval details
- PMA number
- P200035
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2024-11-12
- Decision date
- 2025-04-16
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- Approval for an additional manufacturing line at Raumedic for the Disposable Set (D0146) component of the OrganOx metra System.
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