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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP860004
Supplement NumberS167
Date Received12/28/2011
Decision Date02/17/2012
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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