OrganOx metra® System
FDA premarket approval P200035/S014 · decided 2024-03-28
Approval details
- PMA number
- P200035
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- 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
- 2024-02-02
- Decision date
- 2024-03-28
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- approval to change the OrganOx metra Liver Perfusion Circuit (Part Number D0146). The change included the replacement of the tubing for the Bile Duct Cannulation Pack due to a supply shortage of the original cannula
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