FDA.reportPublic FDA data

PMA P860003S069

Device
THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S069
Product code
LNR
Decision date
2013-02-15
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
APPROVAL FOR LABELING MODIFICATIONS TO INCLUDE A WARNING STATEMENT REGARDING THE USE OF THE DEVICE ON THE SAME DAY AS OTHER PROCEDURES THAT MAY CAUSE SIGNIFICANT FLUID CHANGES IN A PATIENT.

Current openFDA PMA Record#

Device
THERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S069
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2013-02-15
Decision code
APPR
Date received
2013-01-14
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR LABELING MODIFICATIONS TO INCLUDE A WARNING STATEMENT REGARDING THE USE OF THE DEVICE ON THE SAME DAY AS OTHER PROCEDURES THAT MAY CAUSE SIGNIFICANT FLUID CHANGES IN A PATIENT.