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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.
Classification Namepump, infusion, implanted, programmable
Generic Nameindura/piece intrathecal catheter with sutureless connector
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 - component
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.