|Trade Name||MEDTRONIC SYNCHROMED II IMPLANTABLE PROGRAMMABLE DRUG INFUSION SYSTEM|
|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: 1) change the composition of the motor coil pin connector material from a phosphor bronze containing some lead to a lead-free phosphor bronze; and 2) modify the weld coating process from one large mound of silicone varnish over both motor coil connector pins to individual mounds over each pin.