OrganOx metra System
FDA premarket approval P200035/S016 · decided 2024-08-23
Approval details
- PMA number
- P200035
- Supplement
- S016
- 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
- 2024-08-06
- Decision date
- 2024-08-23
- Days to decision
- 17 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- a component change of oxygen concentrator
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