|Trade Name||SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||implantable infusion pumps|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes involving the motor coil for the synchromed ii implantable infusion pump: 1) change from a crimped to a heat-welded motor coil connector pin; and 2) change to a silicon varnish surface coating of the motor coil, the same coating as applied to the motor coil of the synchromed el implantable infusion pump.