|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||BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| express gmp supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional manufacturing facility located at boston scientific/scimed, inc. , plymouth, minnesota 55442 and an additional sterilization facility located at iba, willowbrook, illinois 60521.