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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.
 
Device THERAKOS UVAR XTS PHOTOPHERESIS SYSTEM
Generic NameSystem, photopheresis, extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS077
Date Received11/12/2014
Decision Date02/03/2015
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE POLYPROPYLENE MATERIAL USED FOR THEEFFLUENT TUBE OF THE CENTRIFUGE BOWLS IN THE UVAR XTS® PHOTOPHERESIS SYSTEM PROCEDURAL KITS.
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