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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.
 
DeviceCODMAN 3000 IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
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.
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