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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 NumberP860004
Supplement NumberS108
Date Received07/06/2009
Decision Date09/04/2009
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) updated manuals with the general term "plastic" to describe the new hub/cap material and added other minor clarifications; 2) added compartment to form an inner tray to contain accessories - eliminates bagging and reduces manufacturing cost; 3) inner tray is placed in an outer tray and sealed with a polyethylene lid; 4) inner tray, inner lid and outer tray material changed to polyethylene terephthalate (pet) for improved recycling; and 5) modified box to accommodate new tray design and additional (european) languages in manuals.