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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUVAR PHOTOPHORESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC., JOHNSON & JOHNSON
PMA NumberP860003
Supplement NumberS027
Date Received10/05/1995
Decision Date05/17/1996
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the manufacturing facility for the tps102 photoceptor component of the uvar photopheresis system from therakos to harmac medical products at 2201 bailey avenue in buffalo, new york (establishment registration #1317547).
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