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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceISOMED IMPLANTABLE FLOW INFUSION PUMP
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP990034
Supplement NumberS003
Date Received09/04/2002
Decision Date11/08/2002
Product Code LKK 
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination ProductNo
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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