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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 / THERAKOS UVAR XTS PHOTOPHERESIS SYSTEMS
Generic NameSystem, photopheresis, extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS069
Date Received01/14/2013
Decision Date02/15/2013
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS TO INCLUDE A WARNING STATEMENT REGARDING THE USE OF THE DEVICE ON THE SAME DAY AS OTHER PROCEDURES THAT MAY CAUSE SIGNIFICANT FLUID CHANGES IN A PATIENT.
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