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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.
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS048
Date Received06/11/2008
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/material
Expedited Review Granted? No
Combination Product Yes
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.