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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 UVAR XTS PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS065
Date Received02/01/2012
Decision Date03/02/2012
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 a technical bulletin (technical bulletin xts #1) that will be sent out to users of the uvar xts photopheresis system.
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