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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.
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS043
Date Received10/18/1999
Decision Date10/29/1999
Product Code LKK 
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a design change to the Model 8703W intraspinal catheter. The resulting catheter incorporates the same materials and basic design as Model 8703W except for a closed distal tip with six side holes instead of a single open tip. The device, as modified, will be marketed under the trade name Medtronic(R) Model 8711 Two Piece Intrathecal Catheter and is indicated for the containment and delivery of parenteral drugs to the intrathecal space of the spinal cord.