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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 NameMEDSTREAM PROGRAMMABLE INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP890055
Supplement NumberS055
Date Received04/28/2014
Decision Date05/22/2014
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to quality control and manufacturing procedures to include additional steps verifying that a minimum of 66 hours have elapsed between the time that the medstream pump battery is connected to the printed circuit board (pcb) and before programming the pcb with the production diagnostic pump software.
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