| 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. |
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| Device | INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR/INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR |
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| Generic Name | Pump, infusion, implanted, programmable |
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| Applicant | Medtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432 |
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| PMA Number | P860004 |
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| Supplement Number | S167 |
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| Date Received | 12/27/2011 |
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| Decision Date | 02/17/2012 |
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| Product Code |
LKK |
| Advisory Committee |
General Hospital |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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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