|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 AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM|
|Classification Name||stent, iliac|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a product line extension that represents modifications to the 6fr version of the zilver vascular stent. In addition, approval of minor changes to the stent and delivery system and the addition of a 100 mm length stent. The device, as modified, will be marketed under the trade name zilver flex 35 vascular stent 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.