PMA P860003S045

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S045
Product code: LNR
Decision date: 2006-12-22
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A MATERIAL CHANGE FOR THE SPIKE PORTION OF THE DRIP CHAMBER OF THE UVAR XTS PROCEDURAL KIT, WHICH IS USED WITH THE UVAR XTS PHOTOPHERESIS SYSTEM.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S045
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2006-12-22
Decision code: APPR
Date received: 2006-11-22
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MATERIAL CHANGE FOR THE SPIKE PORTION OF THE DRIP CHAMBER OF THE UVAR XTS PROCEDURAL KIT, WHICH IS USED WITH THE UVAR XTS PHOTOPHERESIS SYSTEM.