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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.
 
Trade NameMEDTRONIC MODEL 8711 TWO PIECE INTRATHECAL CATHETER
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS043
Date Received10/18/1999
Decision Date10/29/1999
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 No
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.
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