OrganOx metra® System
FDA premarket approval P200035/S010 · decided 2023-08-09
Approval details
- PMA number
- P200035
- Supplement
- S010
- 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
- 2023-06-30
- Decision date
- 2023-08-09
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- Approval for replacing OrganOx metra Liver Perfusion Circuit (Part Number D0146) IVC cannula component model RV40028 with model V122-28.
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