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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
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS102
Date Received02/03/2020
Decision Date07/31/2020
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for software Version 5.4 and for hardware modifications to the CELLEX® Photopheresis System, including changes to the servo drive electrical isolation hardware and to the Ballast Monitor and Lamp Rear printed circuit board assemblies.
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