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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.
Classification Namepump, infusion, implanted, programmable
PMA NumberP990034
Supplement NumberS020
Date Received09/07/2010
Decision Date10/07/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval to update the labeling for these devices to specifically state cephalad migration of catheter fragments as part of the adverse event summaries in the devices¿ information for prescribers manuals and user manuals.