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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
ApplicantMallinckrodt Pharmaceuticals Ireland 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
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S047 S048 S049 S050 S051 
S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 
S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S088 
S089 S090 S092 S093 S094 S095 S096 S097 S098 S099 S100 S101 
S102 S103 S104 S105 S106 S107 S108 S109 S110 
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