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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 NumberS028
Date Received01/30/1997
Decision Date03/25/1997
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of external biological indicators to monitor the sterilizatin cycles for the photopheresis tps101 blood tubing set, tps102 photoceptor(r), and a commercially available blood centrifuge bowl.
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