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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 XTS PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC., JOHNSON & JOHNSON
PMA NumberP860003
Supplement NumberS034
Date Received11/05/1999
Decision Date11/29/1999
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a change in the sterilization process to place the biological indicator, that is normally placed inside of the treatment kit packaging, in an external challenge device on the outside of the kits.
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