PMA P860003S073

Device: THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S073
Product code: LNR
Decision date: 2013-05-06
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: MANUFACTURING PROCESS CHANGE FOR ONE OF THE CELLEX SYSTEM COMPONENTS.

Current openFDA PMA Record#

Device: THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHERESIS PROCEDURAL KIT (125ML) THERAKOS CELLEX LIGHT ASSEMBLY
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S073
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2013-05-06
Decision code: OK30
Date received: 2013-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE FOR ONE OF THE CELLEX SYSTEM COMPONENTS.