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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 KIT
Generic NameSystem, photopheresis, extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS075
Date Received02/10/2014
Decision Date05/09/2014
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 GEOMETRY OF THE STAND-OFFS FEATURED ON THE INNER LOWER BOWL COVER OF THE CELLEX® PROCEDURAL KIT¿S CENTRIFUGE BOWL
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