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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.
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
7000 central avenue ne
minneapolis, MN 55432-3576
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/material
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.