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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.
 
DeviceSYNCHROMED AND ISOMED IMPLANTABLE INFUSION PUMPS: MEDTRONIC MODEL 8840 N?VISION PROGRAMMING SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS083
Date Received05/01/2006
Decision Date07/05/2006
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 CHANGES TO THE PLATFORM SOFTWARE ON THE MODEL 8840 N'VISION PROGRAMMING SYSTEM.
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