FDA.reportPublic FDA data

PMA P860003S102

Device
Therakos CELLEX Photopheresis System
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S102
Product code
LNR
Decision date
2020-07-31
Generic name
System, photopheresis, extracorporeal
Approval order statement
Approval for software Version 5.4 and for hardware modifications to the CELLEX® Photopheresis System, including changes to the servo drive electrical isolation hardware and to the Ballast Monitor and Lamp Rear printed circuit board assemblies.

Current openFDA PMA Record#

Device
Therakos CELLEX Photopheresis System
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S102
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2020-07-31
Decision code
APPR
Date received
2020-02-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software Version 5.4 and for hardware modifications to the CELLEX® Photopheresis System, including changes to the servo drive electrical isolation hardware and to the Ballast Monitor and Lamp Rear printed circuit board assemblies.