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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 DRUG DELIVERY SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS027
Date Received11/24/2010
Decision Date12/22/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a parametric release process for ethylene oxide sterilized products.
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