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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 NumberS175
Date Received08/28/2012
Decision Date01/07/2013
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 a minor design control change, and subsequent manufacturing process changes, to remove the lack of lamination note from the pump and spinal catheter segments assembly level prints for the device.