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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 NumberS093
Date Received07/10/2017
Decision Date01/28/2018
Product Code 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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing site located at Harmac Medical Products Limited , I.D.A Industrial EstateCastlerea Roscommon, Ireland for the manufacture and finished product release testing for CELLEX Procedural Kits ; Synergy Health Ireland Ltd , IDA Industrial Estate , Tullamore, Offaly, Ireleand for the sterilization of CELLEX Procedural Kits; and Synergy Health (Steris), Thorne, UK Ltd , Alpha Court Capitol Park, Thorne, South Yorkshire DN8 5TZ, United Kingdom, as the alternate sterilization location for the CELLEX Procedural Kits
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