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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 SYSTEMS
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS064
Date Received01/24/2012
Decision Date04/04/2012
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for labeling changes to ensure the appropriate dosing of heparin for low body weight patients.
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