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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.
 
DeviceCONSTANT FLOW IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS009
Date Received02/23/1999
Decision Date01/21/2000
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding the drug lioresal (baclofen) to the list of drugs approved for use with the model 3000-16 and model 3000-50 implantable drug delivery pumps. Also, the label will clearly indicate that baclofen is stable for 44 days at 37c.
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