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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
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP990034
Date Received06/28/1999
Decision Date07/21/2000
Product Code
LKK[ Registered Establishments with LKK ]
Docket Number 00M-1495
Notice Date 09/21/2000
Advisory Committee General Hospital
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 
S022 S023 S024 S025 S026 S029 S031 S032 S033 
S035 S036 S038 
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