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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 ONE PIECE VASCULAR CATHETERS
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS045
Date Received03/29/2000
Decision Date04/14/2000
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in the anchor rings - the anchor rings at the tip of the model 8700a catheter are to be changed from a tapered design to a smaller, rounded bead design at the distal end of the catheter; changes to the catheter tubing composition - the composition of the tubing for the model 8700a, model 8700v, and model 8702 catheters is to be changed to biomedical grade etr q7-4765; changes to the technical manual - the model 8700a, model 8700v, and model 8702 catheters are covered in the same technical manual.
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