|Trade Name||S7 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM|
|Classification Name||stent, coronary|
|Generic Name||cardiovascular stent|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the s7 with discrete technology(tm) over-the-wire (otw) and rapid exchange (rz) coronary stent systems. The devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions (length <= 30 mm) in native coronary arteries with reference vessel diameters ranging from 3. 0 mm and 4. 0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present. The rx relivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only the rapid exchange stent delivery system is not intended for use as a stand alone ptca perfusion catheter.