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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.
 
DeviceMEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave, Suite 300A
Newton, MA 02459
PMA NumberP890055
Date Received09/28/1989
Decision Date03/11/1996
Product Code LKK 
Docket Number 96M-0239
Notice Date 07/16/1996
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODEL 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S038 
S039 S040 S041 S043 S045 S046 S047 S048 S049 S050 S051 S052 
S053 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 
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