This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the zilver vascular stent. This device 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.
| Device | ZILVER VASCULAR STENT |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Cook Incorporated |
| Date Received | 2005-04-15 |
| Decision Date | 2006-06-26 |
| Notice Date | 2006-07-26 |
| PMA | P050017 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 06M-0294 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cook Incorporated p.o.box 489 bloomington, IN 47402 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050017 | Original Filing | |
| S019 | 2022-03-07 | 30-day Notice |
| S018 | 2020-01-08 | 30-day Notice |
| S017 | 2019-02-19 | 30-day Notice |
| S016 | 2018-05-30 | 30-day Notice |
| S015 | 2017-03-07 | 30-day Notice |
| S014 | 2016-11-18 | Special (immediate Track) |
| S013 | 2016-06-02 | 30-day Notice |
| S012 | 2015-08-05 | 30-day Notice |
| S011 | 2015-07-15 | Special (immediate Track) |
| S010 | 2014-07-15 | 30-day Notice |
| S009 | 2014-04-17 | Normal 180 Day Track No User Fee |
| S008 | 2013-07-25 | 30-day Notice |
| S007 | ||
| S006 | 2011-04-04 | Normal 180 Day Track |
| S005 | 2010-02-19 | Real-time Process |
| S004 | 2008-08-20 | Normal 180 Day Track |
| S003 | 2008-07-10 | Normal 180 Day Track No User Fee |
| S002 | 2008-03-10 | Normal 180 Day Track No User Fee |
| S001 | 2007-10-11 | 30-day Notice |