OrganOx metra® System
FDA premarket approval P200035/S007 · decided 2023-11-20
Approval details
- PMA number
- P200035
- Supplement
- S007
- 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
- 2023-02-17
- Decision date
- 2023-11-20
- Days to decision
- 276 days
- Decision code
- APPR
- Product code
- QQK
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Oxford
- Statement
- This 180-day PMA supplement requested approval for changes to the hardware and software of the OrganOx metra Retained Unit (Part Number D0003). These changes include the update of hardware components due to obsolescence and to facilitate electrical safety and electromagnetic compatibility (EMC) testing compliance. In addition, the software Operating System (OS) is updated from Windows 7 to Windows 10 and the Graphical User Interface (GUI) component of the system software is updated to accommodat
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