PMA P200035S033

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S033
Product code: QQK
Decision date: 2026-05-21
Classification: Gastroenterology, Urology
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement: addition of a new manufacturing site (Raumedic, Inc., Mills River, NC, USA) and sterilization site (Isomedix Operations, Inc., Spartanburg, SC, USA) for the OrganOx metra Disposable Set (D0146-US)

Current openFDA PMA Record#

Device: OrganOx metra® System
Applicant: Organox Limited
PMA number: P200035
Supplement: S033
Product code: QQK
Generic name: Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date: 2026-05-21
Decision code: APPR
Date received: 2025-12-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new manufacturing site (Raumedic, Inc., Mills River, NC, USA) and sterilization site (Isomedix Operations, Inc., Spartanburg, SC, USA) for the OrganOx metra Disposable Set (D0146-US)