PMA P860003S059

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S059
Product code: LNR
Decision date: 2011-05-13
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO A Y-ADAPTOR IN THE CELLEX PROCEDURAL KIT AND A CHANGE IN THE SPLICE BOND BUSHING OF THE CELLEX PROCEDURAL KITS ANTICOAGULANT (GREEN) LINE.

Current openFDA PMA Record#

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM PROCEDURAL KIT
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S059
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2011-05-13
Decision code: APPR
Date received: 2011-03-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MINOR DIMENSIONAL CHANGE TO A Y-ADAPTOR IN THE CELLEX PROCEDURAL KIT AND A CHANGE IN THE SPLICE BOND BUSHING OF THE CELLEX PROCEDURAL KITS ANTICOAGULANT (GREEN) LINE.