|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||ZILVER VASCULAR STENT|
|Classification Name||stent, iliac|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification from the existing over-the-wire delivery system to a rapid exchange delivery system for the device. The device, as modified, will be marketed under the trade name zilver vascular stent with rapid exchange delivery system and is indicated for use as an adjunct to percutaneous transluminal angioplasty (pta) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for pta and stent treatment.