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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 INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS054
Date Received09/16/2002
Decision Date10/11/2002
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8731: 1) PRE-ATTACHED TWO-PIECE CONNECTOR/ANCHOR 2) CATHETER TUBING MATERIAL WITH IMPROVED PHYSICAL PROPERTIES, 3) CATHETER TIP WITH IMPROVED RADIOPACITY, 4) LONGER INTRODUCER NEEDLE WITH DEPTH MARKINGS, 5) REVISION KITS (MODELS 8596 AND 8598), AND 6) CATHETER PASSER KITS (MODEL 8583 & 8686). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 8731 CLOSED-TIP INTRATHECAL CATHETER AND IS INDICATED FOR USE WITH THE MEDTRONIC SYNCHROMED OR ISOMED IMPLANTABLE INFUSION PUMP SYSTEMS TO ADMINISTER PARENTERAL DRUGS.
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