|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 IMPLANTABLE INFUSION SYSTEM|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||pump, infusion, implanted, programmable|
|Supplement Type||special (immediate track)|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the medtronic model 8840 n'vision programmer technical manual to add a precaution to identify an environment in which the device is not certified for use.