PMA P860003S083

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S083
Product code: LNR
Decision date: 2016-04-08
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for a change in the color scheme of the anticoagulant line from green-striped to orange-striped, and in the color of the anticoagulant spike chamber from white to orange.

Current openFDA PMA Record#

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S083
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2016-04-08
Decision code: APPR
Date received: 2016-01-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change in the color scheme of the anticoagulant line from green-striped to orange-striped, and in the color of the anticoagulant spike chamber from white to orange.