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PMA P200035S031

Device
OrganOx metra® System
Applicant
Organox Limited
PMA number
P200035
Supplement
S031
Product code
QQK
Decision date
2025-12-17
Classification
Gastroenterology, Urology
Generic name
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Approval order statement
to move the manufacturing location for em-tec GmbH, the manufacturer of the SonoTT Flowmessboard Digiflow Mini and the SonoTT™ Clamp-On Transducer from Am Graben 6–8, 86923 Finning, Germany to their registered address of Lerchenberg 20, 86923 Finning, Germany

Current openFDA PMA Record#

Device
OrganOx metra® System
Applicant
Organox Limited
PMA number
P200035
Supplement
S031
Product code
QQK
Generic name
Normothermic machine perfusion system for the preservation of donor livers prior to transplantation
Decision date
2025-12-17
Decision code
OK30
Date received
2025-11-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to move the manufacturing location for em-tec GmbH, the manufacturer of the SonoTT Flowmessboard Digiflow Mini and the SonoTT™ Clamp-On Transducer from Am Graben 6–8, 86923 Finning, Germany to their registered address of Lerchenberg 20, 86923 Finning, Germany