PMA P860003S104

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S104
Product code: LNR
Decision date: 2021-10-01
Generic name: System, photopheresis, extracorporeal
Approval order statement: Moving production of the Servo Isolation Module PCBA (Printed Circuit Board Assembly) Assembly (PN-1260019) from EAS to a new supplier, Saline Lectronics.

Current openFDA PMA Record#

Device: THERAKOS CELLEX Photopheresis System (CELLEX), THERAKOS CELLEX Photopheresis Procedural Kit (CLXUSA/CLXECP),THERAKOS CEL
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S104
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2021-10-01
Decision code: OK30
Date received: 2021-09-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Moving production of the Servo Isolation Module PCBA (Printed Circuit Board Assembly) Assembly (PN-1260019) from EAS to a new supplier, Saline Lectronics.