OrganOx metra System
FDA premarket approval P200035/S012 · decided 2023-10-27
Approval details
- PMA number
- P200035
- Supplement
- S012
- 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
- 2023-09-28
- Decision date
- 2023-10-27
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- approval for an amendment to the OrganOx metra New Enrollment PAS (P200035/PAS003) protocol to include a study arm with the goal of collecting data on livers from DCD donors older than 40 years of age, perfused with the OrganOx metra and transplanted in adult recipients
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