|Trade Name||SYNCHROMED II INFUSION PUMP|
|Classification Name||pump, infusion, implanted, programmable|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for incorporating additional inspections and minor tooling modifications to minimize the potential for the pump tube component to be damaged during the pump manufacturing process of the synchromed ii infusion system, model 8637.