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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 INTRATHECAL CATHETER MODEL 8731, MEDTRONIC INFUSION PUMP SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS054
Date Received09/16/2002
Decision Date10/11/2002
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 the following changes to intrathecal catheter model 8731: 1) pre-attached two-piece connector/anchor 2) catheter tubing material with improved physical properties, 3) catheter tip with improved radiopacity, 4) longer introducer needle with depth markings, 5) revision kits (models 8596 and 8598), and 6) catheter passer kits (model 8583 & 8686). The device, as modified, will be marketed under the trade name medtronic model 8731 closed-tip intrathecal catheter and is indicated for use with the medtronic synchromed or isomed implantable infusion pump systems to administer parenteral drugs.
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