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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 3000 IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
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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