FDA.reportPublic FDA data

PMA P860003S086

Device
THERAKOS UVAR XTS Photopheresis System Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S086
Product code
LNR
Decision date
2016-05-05
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
Manufacturing process change to the exterior printing of the Tyvek lid stock for the Therakos UVAR XTS Procedural Kit used with the Therakos UVAR XTS Photopheresis System.

Current openFDA PMA Record#

Device
THERAKOS UVAR XTS Photopheresis System Procedural Kit
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S086
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2016-05-05
Decision code
OK30
Date received
2016-04-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing process change to the exterior printing of the Tyvek lid stock for the Therakos UVAR XTS Procedural Kit used with the Therakos UVAR XTS Photopheresis System.