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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.
 
DeviceINFUSION PUMP
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS092
Date Received08/31/2007
Decision Date11/21/2007
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR SOFTWARE UPDATES MADE TO N?VISION PROGRAMMING SYSTEM MODEL 8840.
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