PMA P860003S070

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S070
Product code: LNR
Decision date: 2013-02-19
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: MANUFACTURING PROCESS CHANGE TO APPLY A CURRENTLY USED UV CURABLE ADHESIVE IN AN ADDITIONAL LOCATION WITHIN THE CELLEX PHOTOPHERESIS PROCEDURAL KIT.

Current openFDA PMA Record#

Device: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S070
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2013-02-19
Decision code: OK30
Date received: 2013-01-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING PROCESS CHANGE TO APPLY A CURRENTLY USED UV CURABLE ADHESIVE IN AN ADDITIONAL LOCATION WITHIN THE CELLEX PHOTOPHERESIS PROCEDURAL KIT.