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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.
 
DeviceINTRATHECAL CATHETER MODELS 8709, 8711, 8709SC, 8731SC, AND REVISION KIT 8598A
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS088
Date Received11/08/2006
Decision Date05/01/2007
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: 1) A NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 2) A MODIFIED MANUFACTURING MONITORING PROCESS TO ASSURE CONFORMANCE TO NEW CATHETER TIP PUSH-OUT FORCE SPECIFICATION; 3) A CHANGE TO THE CATHETER TIP MATERIAL FOR CATHETER MODEL 8731SC AND REVISION KIT MODEL 8598A; AND 4) LABELING REVISIONS.
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