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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTHERAKOS® CELLEX® Photopheresis System (CELLEX), THERAKOS® CELLEX® Photopheresis Procedural Kit (CLXUSA and CLXECP), THE
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS112
Date Received03/24/2025
Decision Date11/21/2025
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing changes to the blood and air filter component of the pump tubing organizer in the THERAKOS® CELLEX® Procedural Kit wherein the raw material supplier is changed, and the washing line equipment is updated.
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