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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 SYSTEMS
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
PMA NumberP860003
Supplement NumberS064
Date Received01/24/2012
Decision Date04/04/2012
Product Code LNR 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES TO ENSURE THE APPROPRIATE DOSING OF HEPARIN FOR LOW BODY WEIGHT PATIENTS.
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