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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameUVAR PHOTOPHERESIS SYSTEM
Classification Namesystem, photopheresis, extracorporeal
Generic Nameuvar photopherssis system
ApplicantTHERAKOS, INC.
PMA NumberP860003
Date Received01/24/1986
Decision Date04/08/1987
Product Code
LNR[ Registered Establishments with LNR ]
Docket Number 87M-0136
Notice Date 05/18/1987
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH 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 
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