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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameISOMED IMPLANTABLE FLOW INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pump
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS003
Date Received09/04/2002
Decision Date11/08/2002
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing, packaging and sterilization facility at medtronic neurological and spinal division, columbia heights, minnesota.
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