This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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.
| Device | ZILVER VASCULAR STENT AND ZILVER VASCULAR STENT WITH RAPID EXCHANGE DELIVERY SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | Cook Incorporated |
| Date Received | 2011-04-04 |
| Decision Date | 2011-07-05 |
| PMA | P050017 |
| Supplement | S006 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cook Incorporated p.o.box 489 bloomington, IN 47402 |
| 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 |