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PMA P860003S034

Device
UVAR XTS PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S034
Product code
LNR
Decision date
1999-11-29
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.

Current openFDA PMA Record#

Device
UVAR XTS PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S034
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
1999-11-29
Decision code
OK30
Date received
1999-11-05
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
The 30-Day Notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.