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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 INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS051
Date Received04/29/2002
Decision Date05/14/2002
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 CHANGES TO INTRATHECAL CATHETER MODEL 8711: 1) ADDITION OF NUMERICAL MARKINGS (IN CM) ON THE CATHETER TUBING, 2) CHANGE IN V-WING ANCHOR MATERIAL FOR IMPROVED VISIBILITY, 3) REMOVAL OF PROXIMAL ANCHOR; TUNNELING ROD TIPS AND WRENCH FROM THE CATHETER KIT, AND 4) UPDATE MODEL 8711 TECHNICAL MANUAL TO PROVIDE DETAILED INSTRUCTIONS AND CAUTIONS.
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