PMA P860003S077

Device: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S077
Product code: LNR
Decision date: 2015-02-03
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR A CHANGE IN THE POLYPROPYLENE MATERIAL USED FOR THEEFFLUENT TUBE OF THE CENTRIFUGE BOWLS IN THE UVAR XTS® PHOTOPHERESIS SYSTEM PROCEDURAL KITS.

Current openFDA PMA Record#

Device: THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S077
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2015-02-03
Decision code: APPR
Date received: 2014-11-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN THE POLYPROPYLENE MATERIAL USED FOR THEEFFLUENT TUBE OF THE CENTRIFUGE BOWLS IN THE UVAR XTS® PHOTOPHERESIS SYSTEM PROCEDURAL KITS.