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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 NumberS020
Date Received08/06/2007
Decision Date08/23/2007
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change 1) in packaging location for the barbed catheter connector to an in-house procedure at codman & shurtleff, raynham, massachusetts from avid medical, roano, virginia, and 2) change in the barbed catheter connector packaging to the approved packaging for the flex 1 replacement connector.
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