|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||SCIMED RADIUS CORONARY STENT WITH DELIVERY SYSTEM|
|Applicant||BOSTON SCIENTIFIC SCIMED, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval study protocol - ode/oir|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Proposal for 5 year post-approval study protocol.