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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUVAR CELLEX PHOTOPHERESIS SYSTEM
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS048
Date Received06/11/2008
Decision Date03/20/2009
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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.
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