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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 NameVASCULAR CATHETER
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS050
Date Received04/23/2002
Decision Date05/02/2002
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 catheter model 8708 in which the straight connector is replaced with right angle connector, the number of anchor beads is increased to 12. Also, removal of accessory components specified as guide wire, tunneling accessories and two pre-attached anchors from model 8700a, 8700v and 8702 package. The device, as modified, will be marked under the trade name medtronic vascular catheter model 8708 and is indicated for use with the medtronic implantable infusion pumps to provide fluid pathway.
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