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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(R) PHOTOPHORESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameextracorporeal photopheresis system
ApplicantTHERAKOS, INC., JOHNSON & JOHNSON
PMA NumberP860003
Supplement NumberS025
Date Received02/09/1995
Decision Date10/03/1996
Product Code
LNR
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for packaging the three disposable treatment components (tps101 blood tubint set, tps102 photoceptor, and a commercially available blood centrifuge bowl) into a singel procedural kit prior to sterilization; 2) packaging three procedural kits together in a single overshipper carton; 3) changing the sterilization cycle to oe which provides for alonger exposure time, higher concentrations of ethylene oxide, and allows for a cooler product temperature at the beginning of the exposure phase of the cycle; and 4) the use of one thermocouple in each pallet to monitor product temperature during routine sterilization.
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