|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SYNCHROMED II PUMP MODEL 8637|
|Classification Name||pump, infusion, implanted, programmable|
|Applicant|| MEDTRONIC INC.|
|Supplement Type|| Special Supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for labeling changes to the sterile package, shelf box label and implant manual to reflect a new warning which states ¿warning: keep away from magnets. ¿.