|Trade Name||ISOMED CONSTANT FLOW INFUSION PUMP|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||pump, infusion, implanted, programmable|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications to the model 8472 pump: 1) modification of the mounting of the bellows infusate reservoir; 2) slight changes in the configuration of five component parts in order to maintain the heights of the pumps following the change in mounting; and 3) required changes in five welds to facilitate the previously stated modifications.