|Trade Name||S7 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of an optional mechanical fixation step to the stent securement process. The device, as modified, will be marketed under the trade name s7 with discrete technology over-the-wire coronary stent system and is indicated for the improvement of coronary luminal diameter.