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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 AND REVISION KITS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS136
Date Received07/08/2010
Decision Date12/15/2011
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES: 1) MODEL 8709SC INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 2) MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 3) MODEL 8596SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR; AND 4) MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT FOR MODEL 8709 AND MODEL 8709SC INTRATHECAL CATHETERS.
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