|Trade Name||MEDSTREAM PROGRAMMABLE INFUSION SYSTEM|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||pump, infusion, implanted, programmable|
|Supplement Type||special (immediate track)|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| 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.