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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 NameTHERAKOS CELLEX / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS069
Date Received01/16/2013
Decision Date02/15/2013
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling modifications to include a warning statement regarding the use of the device on the same day as other procedures that may cause significant fluid changes in a patient.
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