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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 Procedural Kit
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS101
Date Received02/12/2019
Decision Date05/13/2019
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 design changes to the pump tubing organizer assembly of the Therakos CELLEX Procedural Kit.
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