|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||MEDTRONIC SYNCHROMED INFUSION SYSTEM|
|Classification Name||pump, infusion, implanted, programmable|
|Generic Name||implantable infusion pumps|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the prescription caution statement on the synchromed prouduct labeling from "caution: federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 cfr 801. 109(b)(1), "caution: federal law restricts this device to sale by or on the order of a physician". Fda also acknowledges and approves the substitution of "(usa)" for "federal law" for devices distributed outside of the united states.