OrganOx metra System
FDA premarket approval P200035/S003 · decided 2022-07-07
Approval details
- PMA number
- P200035
- Supplement
- S003
- 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
- 2022-06-07
- Decision date
- 2022-07-07
- Days to decision
- 30 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 studies (PAS) protocol.
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