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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.
 
DeviceMEDTRONIC ISOMED INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP990034
Date Received06/28/1999
Decision Date07/21/2000
Product Code LKK 
Docket Number 00M-1495
Notice Date 09/21/2000
Advisory Committee General Hospital
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MEDTRONIC(R) ISOMED(R) CONSTANT FLOW INFUSION SYSTEM. THIS DEVICE IS INDICATED FOR USE WHEN PATIENT THERAPY REQUIRES THE CHRONIC INFUSION OF APPROVED DRUGS OR FLUIDS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S006 S003 S020 S004 S019 S010 S014 S015 S011 S017 S018 S035 
S012 S016 S001 S002 S021 S022 S023 S024 S025 S026 S031 S032 
S033 S013 S005  S029 S036 S045 S038 S039 S041 S044 S042 
S043 
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