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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 Procedural Kit
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS113
Date Received06/02/2025
Decision Date06/30/2025
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
This 30-Day Notice is to update the Outer Bowl Cover specification to include a flash specification and to implement a Quality Control inspection process for excess flash at CMO (Harmac) of the THERAKOS® CELLEX® Photopheresis System Procedural Kit from Therakos Development Limited.
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