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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.
 
DeviceMEDTRONIC SYNCHROMED APPLICATION SOFTWARE FOR MODEL 8870, MEDTRONIC INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS055
Date Received11/29/2002
Decision Date12/17/2002
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING TWO CHANGES TO THE 8870 SYNCHROMED APPLICATION SOFTWARE, APPROVED AS P860004/S052, FOR USE WITH THE N'VISION PROGRAMMING SYSTEM CONTAINED ON MODEL 8870 APPLICATION CARD. THE SPECIFIC CHANGES ARE: 1) A CHANGE TO THE 8870 SYNCHROMED APPLICATION PROTOCOL DRIVER TO ENSURE SYNCHRONIZATION AND 2) A MICROPROCESSOR-RESET FEATURE TO THE THERAPY STOP FUNCTION TO RESET THE STACK POINTER.
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