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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.
 
DeviceTHERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Namesystem, photopheresis, extracorporeal
Applicant
THERAKOS, INC.
440 route 22 east
suite 140
bridgewater, NJ 08807
PMA NumberP860003
Supplement NumberS025
Date Received02/09/1995
Decision Date10/03/1996
Product Code
LNR[ Registered Establishments with LNR ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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