PMA P860003S048

Device: UVAR CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S048
Product code: LNR
Decision date: 2009-03-20
Classification: System, Photopheresis, Extracorporeal
Generic name: System, photopheresis, extracorporeal
Approval order statement: APPROVAL FOR ENGINEERING AND DESIGN CHANGES TO THE UVAR XTSPHOTOPHERESIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETHERAKOS CELLEX PHOTOPHERESIS SYSTEM, AND IS INDICATED FOR USE IN THE ULTRAVIOLET-A(UVA) IRRADIATION, IN THE PRESENCE OF THE PHOTOACTIVE DRUG 8-METHOXYPSORALEN (8-MOP), OFEXTRACORPOREALLY CIRCULATING LEUKOCYTE-ENRICHED BLOOD, IN THE PALLIATIVE TREATMENT OF THE SKINMANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA (CTCL), IN PERSONS WHO HAVE NOT BEEN RESPONSIVE TO OTHER FORMS OF TREATMENT.

Current openFDA PMA Record#

Device: UVAR CELLEX PHOTOPHERESIS SYSTEM
Applicant: Therakos Development Limited
PMA number: P860003
Supplement: S048
Product code: LNR
Generic name: System, photopheresis, extracorporeal
Decision date: 2009-03-20
Decision code: APPR
Date received: 2008-06-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ENGINEERING AND DESIGN CHANGES TO THE UVAR XTSPHOTOPHERESIS SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETHERAKOS CELLEX PHOTOPHERESIS SYSTEM, AND IS INDICATED FOR USE IN THE ULTRAVIOLET-A(UVA) IRRADIATION, IN THE PRESENCE OF THE PHOTOACTIVE DRUG 8-METHOXYPSORALEN (8-MOP), OFEXTRACORPOREALLY CIRCULATING LEUKOCYTE-ENRICHED BLOOD, IN THE PALLIATIVE TREATMENT OF THE SKINMANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA (CTCL), IN PERSONS WHO HAVE NOT BEEN RESPONSIVE TO OTHER FORMS OF TREATMENT.