PMA P860003S039

Device: UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S039
Product code: LNR
Decision date: 2001-05-22
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS RELATED TO THE ENUMERATION OF BUFFY COAT MODE CYCLES AND TO THE COLLECTION VOLUME OF BUFFY COAT PRIOR TO THE IRRADIATION PROCESS.

Current openFDA PMA Record#

Device: UVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S039
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2001-05-22
Decision code: APPR
Date received: 2001-03-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR SOFTWARE MODIFICATIONS RELATED TO THE ENUMERATION OF BUFFY COAT MODE CYCLES AND TO THE COLLECTION VOLUME OF BUFFY COAT PRIOR TO THE IRRADIATION PROCESS.