OrganOx metra® System
FDA premarket approval P200035/S002 · decided 2022-05-27
Approval details
- PMA number
- P200035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- 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
- 2022-03-21
- Decision date
- 2022-05-27
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- Approval for the OrganOx metra® New Enrollment PAS. The OrganOx metra® New Enrollment PAS is a multi-center, single-arm, unblinded post-approval study designed to compare recipients of PAS NMP livers versus IDE SCS livers with respect to adverse biliary-related events. Recruitment will take place at a minimum of 10 sites which are UNOS member liver transplant centers.
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