PMA P860003S067

Device: THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S067
Product code: LNR
Decision date: 2012-11-19
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR SOME MINOR CHANGES INTENDED TO REDUCE SPECULAR REFLECTION OF THE KT8L SENSOR'S LASER BEAM AND IMPROVE ITS OPTIC PATH (E.G., REMOVAL OF GLASS PORT, REMOVAL OF RESISTOR, AND ADDITION OF GASKET).

Current openFDA PMA Record#

Device: THERAKOS CELLEX INSTRUMENT, THERAKOS CELLEX PHOTOPHRESSIS PROCEDURAL KIT (125 ML), CLX, THERAKOS CELLEX LIGHT ASSEMBLY ,
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S067
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2012-11-19
Decision code: APPR
Date received: 2012-09-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOME MINOR CHANGES INTENDED TO REDUCE SPECULAR REFLECTION OF THE KT8L SENSOR'S LASER BEAM AND IMPROVE ITS OPTIC PATH (E.G., REMOVAL OF GLASS PORT, REMOVAL OF RESISTOR, AND ADDITION OF GASKET).