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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 PHOTOPHERESIS SYSTEM PROCEDURAL KIT
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS059
Date Received03/14/2011
Decision Date05/13/2011
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a minor dimensional change to a y-adaptor in the cellex procedural kit and a change in the splice bond bushing of the cellex procedural kits anticoagulant (green) line.
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