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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 Procedural Kit
Generic NameSystem, photopheresis, extracorporeal
ApplicantMallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Supplement NumberS100
Date Received12/13/2018
Decision Date01/10/2019
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Change in the manufacturing process for the CELLEX Procedural Kits' drive tube assemblies so that the same manufacturing steps used at the approved Mack Molding manufacturing site can also be used at the approved Harmac Medical, Buffalo, New York site.
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