PMA P860003S044

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S044
Product code: LNR
Decision date: 2006-07-14
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON EXTRACORPOREAL BLOOD VOLUME MANAGEMENT AND THE IMPORTANCE OF TESTING PATIENTS' HEMATOCRIT VALUES.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S044
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2006-07-14
Decision code: APPR
Date received: 2006-06-14
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO INCLUDE INFORMATION ON EXTRACORPOREAL BLOOD VOLUME MANAGEMENT AND THE IMPORTANCE OF TESTING PATIENTS' HEMATOCRIT VALUES.