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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.
 
DeviceUVAR XTS 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 NumberS045
Date Received11/22/2006
Decision Date12/22/2006
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 Yes
Approval Order Statement 
APPROVAL FOR A MATERIAL CHANGE FOR THE SPIKE PORTION OF THE DRIP CHAMBER OF THE UVAR XTS PROCEDURAL KIT, WHICH IS USED WITH THE UVAR XTS PHOTOPHERESIS SYSTEM.
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