OrganOx metra® System
FDA premarket approval P200035/S001 · decided 2022-04-12
Approval details
- PMA number
- P200035
- Supplement
- S001
- 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
- 2022-03-15
- Decision date
- 2022-04-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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