• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
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 Nameextracorporeal photopheresis system
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.