|Trade Name||S7 WITH DIS OVER-THE WIRE CORONARY STENT SYSTEM AND S7 WITH DISCRETE TECHN RAPID EXCHANGE CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the manufacturing process to increase the length and inner diameter of the third and fourth tfe baking sheaths in size to facilitate their application during the stent/balloon baking process.