PMA P860003S108

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S108
Product code: LNR
Decision date: 2022-09-23
Generic name: System, photopheresis, extracorporeal
Approval order statement: Change in the manufacturing process of the American RENOLIT PVC film used in the Cellex procedural kit and Treatment and Return Bags.

Current openFDA PMA Record#

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA and CLXECP), THERAKO
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S108
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2022-09-23
Decision code: OK30
Date received: 2022-08-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the manufacturing process of the American RENOLIT PVC film used in the Cellex procedural kit and Treatment and Return Bags.