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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 NameMEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
ApplicantCODMAN
PMA NumberP890055
Date Received09/28/1989
Decision Date03/11/1996
Product Code
LKK[ Registered Establishments with LKK ]
Docket Number 96M-0239
Notice Date 07/16/1996
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
Approval for model 3000 constant flow implantable infusion pump.
Post-Approval StudyShow Report Schedule and Study Progress
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 
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