Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 Rd.
Dublin D15 TX2V
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: S057 S028 S029 S025 S027 S061 S058 S059 S060  S038 S039 
S069 S070 S081 S062 S033 S051 S049 S031 S032 S048 S030 S036 
S037 S040 S041 S087 S088 S034 S035 S042 S043 S044 S055 S050 
S045 S056 S053 S047 S085 S086 S092 S089 S090 S095 S096 S101 
S104 S105 S106 S110 S112 S097 S098 S093 S094 S099 S113 S063 
S066 S067 S080 S082 S078 S079 S074 S068 S077 S076 S083 S064 
S065 S071 S072 S075 S054 S073 S103 S102 S100 S107 S109 S108 
S111 S084 S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S017 S018 S019 S020 S021 S022 S023 S024 
-
-