PMA P860003S076

Device: THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S076
Product code: LNR
Decision date: 2014-08-21
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: SUPPLIER CHANGE FOR A COMPONENT OF THE LIGHT ASSEMBLIES USED IN THERAKOS UVAR XTS AND CELLEX PHOTOPHERESIS SYSTEMS.

Current openFDA PMA Record#

Device: THERAKOS UVAR XTS AND THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S076
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2014-08-21
Decision code: OK30
Date received: 2014-07-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SUPPLIER CHANGE FOR A COMPONENT OF THE LIGHT ASSEMBLIES USED IN THERAKOS UVAR XTS AND CELLEX PHOTOPHERESIS SYSTEMS.