PMA P200035S015

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S015
Product code: QQK
Decision date: 2024-09-26
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: approval of the revised statistical analysis plan for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200035

Current openFDA PMA Record#

Device: OrganOx metra System
Applicant: Organox Limited
PMA number: P200035
Supplement: S015
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2024-09-26
Decision code: APPR
Date received: 2024-07-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised statistical analysis plan for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P200035