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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 NameTHERAKOS UVAR XTS INSTRUMENT, THERAKOS UVAR XTS PROCEDURAL KIT (125 ML), THERAKOS UVAR XTS PORCEDURAL KIT (225 ML), THEA
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Supplement NumberS066
Date Received09/10/2012
Decision Date11/09/2012
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of 8 ribs to the neck of the centrifuge bowls used in the device and for the accompanying packaging changes.
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