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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceUVAR PHOTOPHERESIS SYSTEM
Generic NameSystem, photopheresis, extracorporeal
ApplicantTherakos Development Limited
College Business & Technology Park
Cruiserath Road
Blanchardstown D15 T
PMA NumberP860003
Date Received01/24/1986
Decision Date04/08/1987
Product Code LNR 
Docket Number 87M-0136
Notice Date 05/18/1987
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Supplements: S047 S031 S032 S045 S033 S049 S034 S035 S051 S055 S042 S043 
S044 S053 S029 S048 S056 S104 S105 S106 S096 S090 S092 S085 
S086 S087 S050 S038 S039 S036 S037 S040 S041 S057 S058 S059 
S060 S061 S062 S063 S064 S065 S075 S076 S077 S078 S079 S080 
S081 S082 S083 S084 S054 S030 S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 S013 S014 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S027 S028  S088 S089 S097 S100 S101 S102 S110 
S111 S093 S094 S095 S098 S099 S103 S109 S108 S107 
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