PMA P860003S038

Device
UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S038
Product code
LNR
Decision date
2001-02-15
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
CHANGE IN THE USE OF DYMAX 29048 UV CURABLE ADHESIVE FOR SEALING THE TWO ACRYLIC PHOTOACTIVATION PLATES TO USING RADIO FREQUENCY WELDING.

Current openFDA PMA Record#

Device
UVAR(R) XTS(R) PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S038
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2001-02-15
Decision code
OK30
Date received
2001-01-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE USE OF DYMAX 29048 UV CURABLE ADHESIVE FOR SEALING THE TWO ACRYLIC PHOTOACTIVATION PLATES TO USING RADIO FREQUENCY WELDING.