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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.
 
DeviceTHERAKOS CELLEX PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
Applicant
THERAKOS, INC.
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS058
Date Received03/08/2011
Decision Date04/21/2011
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional sterilization site located at sterigenics us llc in charlotte, north carolina.
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