OrganOx metra® System
FDA premarket approval P200035/S030 · decided 2025-09-19
Approval details
- PMA number
- P200035
- Supplement
- S030
- Supplement type
- 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
- 2025-08-22
- Decision date
- 2025-09-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- moving the manufacturing of the Disposable Set (D0146) liver bowl clip component from the current manufacturer/supplier, Rutland Plastics, to Fischer Sohne AG
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