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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.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS008
Date Received02/05/1999
Decision Date12/10/1999
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following modifications of the existing Flex Tip Plus Intraspinal Catheter Kit catalog #AP-07008: 1) Addition of a "locking feature" to the current catheter connector design to prevent the connector from being inadvertently opened. 2) Addition of a "stylet" to the kit. 3) Replacement of the blunt flushing needle with the "Snap Lock Flushing Adapter". 4) Addition of the "threading guide" and the "attachable wing hub". 5) Increasing the Flex Tip Plus Intraspinal Catheter length.