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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.
 
DeviceTHERAKOS UVAR(R) PHOTOPHORESIS SYSTEM
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park, Cruiserath Rd.
Dublin D15 TX2V
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 - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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