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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUVAR CELLEX PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS048
Date Received07/08/2008
Decision Date03/20/2009
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for engineering and design changes to the uvar xts photopheresis system. The device, as modified, will be marketed under the trade name therakos 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), 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 forms of treatment.
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