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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.
 
Trade NameCODMAN MODEL 3000 SERIES CONSTANT FLOW IMPLANTABLE PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN
PMA NumberP890055
Supplement NumberS017
Date Received11/24/2003
Decision Date08/18/2004
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at codman & shurtleff, inc. , raynham, massachusetts.
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