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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
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS054
Date Received06/17/2009
Decision Date09/15/2009
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TRANSFER OF FINISHED PRODUCT TESTING TO STERIPRO LABS FROM THERAKOS, INC.
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