PMA P200035S001
- Device
- OrganOx metra® System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S001
- Product code
- QQK
- Decision date
- 2022-04-12
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- OrganOx metra® System
- Applicant
- Organox Limited
- PMA number
- P200035
- Supplement
- S001
- Product code
- QQK
- Generic name
- Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
- Decision date
- 2022-04-12
- Decision code
- APPR
- Date received
- 2022-03-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.