PMA P860003S112

Device: THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S112
Product code: LNR
Decision date: 2025-11-21
Classification: Gastroenterology, Urology
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for manufacturing changes to the blood and air filter component of the pump tubing organizer in the THERAKOS® CELLEX® Procedural Kit wherein the raw material supplier is changed, and the washing line equipment is updated.

Current openFDA PMA Record#

Device: THERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S112
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2025-11-21
Decision code: APPR
Date received: 2025-03-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for manufacturing changes to the blood and air filter component of the pump tubing organizer in the THERAKOS® CELLEX® Procedural Kit wherein the raw material supplier is changed, and the washing line equipment is updated.