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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.
 
DeviceINDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS167
Date Received12/27/2011
Decision Date02/17/2012
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 SUTURELESS CONNECTOR (SC) CATHETER MODELS 8709SC AND 8731SC, AND REVISION KIT MODELS 8578 AND 8596SC TO ADDRESS THE POTENTIAL FOR SIDE LOAD LEAKS. THE MODIFICATION TO YOUR SUTURELESS CONNECTOR ARE AS FOLLOWS: 1) DECREASED THE COUNTER BORE DIAMETER FROM 0.040" TO 0.035"; 2) DECREASED THE DEPTH OF THE COUNTER BORE FROM 0.055" TO 0.050"; 3) INCREASED THE TOLERANCE FOR THE 0.15" DIMENSION OF THE TUBING POSITION FROM +-0.01 TO +-0.02; AND 4) ADDED A REQUIREMENT TO THE PRODUCT SPECIFICATION FOR SIDE LOAD FORCES: CONNECTOR MUST NOT OCCLUDE OR LEAK WHEN PRESSURIZED TO 1.0 +- 0.1 PSIG AIR PRESSURE AND A FORCE OF 4.8 +- 0.1 LBF IS DISTRIBUTED OVER THE CONNECTOR SURFACE AT AN ANGLE OF 12 DEGREES +- 2 DEGREES.
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