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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 NameMEDTRONIC ISOMED INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
Applicant MEDTRONIC INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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 
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