|Trade Name||SYNCHROMED II IMPLANTABLE INFUSION SYSTEM|
|Classification Name||pump, infusion, implanted, programmable|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| 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.