PMA P200035S002

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S002
Product code: QQK
Decision date: 2022-05-27
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: Approval for the OrganOx metra® New Enrollment PAS. The OrganOx metra® New Enrollment PAS is a multi-center, single-arm, unblinded post-approval study designed to compare recipients of PAS NMP livers versus IDE SCS livers with respect to adverse biliary-related events. Recruitment will take place at a minimum of 10 sites which are UNOS member liver transplant centers.

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S002
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2022-05-27
Decision code: APPR
Date received: 2022-03-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval for the OrganOx metra® New Enrollment PAS. The OrganOx metra® New Enrollment PAS is a multi-center, single-arm, unblinded post-approval study designed to compare recipients of PAS NMP livers versus IDE SCS livers with respect to adverse biliary-related events. Recruitment will take place at a minimum of 10 sites which are UNOS member liver transplant centers.