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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
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS023
Date Received10/23/2007
Decision Date11/26/2007
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 the following changes to the flextip plus intraspinal catheter kit and to the codman 3000 pump accessories: 1) replace 3 mm-beveled tuohy needle with a 4 mm-beveled tuohy needle; 2) remove a ruler; 3) replace remaining ruler with a new ruler; 4) reduce aeration time for codman 3000 pump accessories; 5) new packaging design; 6) new packaging materials; 7) update labeling to reflect component changes; and 8) clarify additional non-pyrogenic components and procedural steps.