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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.
 
DeviceUVAR(R) XTS(TM) PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
Applicant
THERAKOS, INC.
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS039
Date Received03/05/2001
Decision Date05/22/2001
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications related to the enumeration of buffy coat mode cycles and to the collection volume of buffy coat prior to the irradiation process.
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