PMA P860003S031

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S031
Product code: LNR
Decision date: 1999-08-10
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy.

Current openFDA PMA Record#

Device: UVAR XTS PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S031
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 1999-08-10
Decision code: APPR
Date received: 1998-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for engineering changes to the UVAR(R) Photopheresis System including the following: 1) Replacing the obsolete Haemotronics centrifuge assembly with the current generation Haemotronics centrifuge assembly that includes an optical detector; 2) Replacing the electronic roller pumps and mechanical clamps with a pneumatically-driven fluid management system, including the cassette, fluid logic module and fluid logic controller; 3) Modifying the Photoceptor(R) photoactivation chamber; 4) Redesigning the treatment kit; and 5) Redesigning the user interface and system software. The device is indicated for use in the ultraviolet-A (UVA) irradiation, in the presence of the photoactive drug methoxsalen (8-methoxypsoralen or 8-MOP), of extracorporeally circulating leukocyte-enriched blood, in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL), in persons who have not been responsive to other therapy.