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 ptx drug-eluting peripheral stent. This device is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.
| Device | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT |
| Classification Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Generic Name | Stent, Superficial Femoral Artery, Drug-eluting |
| Applicant | COOK MEDICAL INCORPORATED |
| Date Received | 2010-06-04 |
| Decision Date | 2012-11-14 |
| Notice Date | 2012-11-30 |
| PMA | P100022 |
| Supplement | S |
| Product Code | NIU |
| Docket Number | 12M-1146 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100022 | Original Filing | |
| S040 | 2021-11-04 | Real-time Process |
| S039 | ||
| S038 | 2021-08-11 | Normal 180 Day Track No User Fee |
| S037 | 2020-11-20 | 30-day Notice |
| S036 | 2020-07-02 | 30-day Notice |
| S035 | 2020-04-16 | 30-day Notice |
| S034 | 2019-09-03 | Special (immediate Track) |
| S033 | ||
| S032 | 2018-12-26 | Real-time Process |
| S031 | 2018-10-11 | 30-day Notice |
| S030 | 2018-10-09 | Normal 180 Day Track No User Fee |
| S029 | 2018-08-09 | 30-day Notice |
| S028 | 2018-08-01 | 30-day Notice |
| S027 | 2018-05-29 | Normal 180 Day Track |
| S026 | 2017-10-30 | Normal 180 Day Track |
| S025 | 2017-06-01 | Real-time Process |
| S024 | 2017-03-13 | 30-day Notice |
| S023 | 2017-03-07 | 30-day Notice |
| S022 | 2017-03-03 | Real-time Process |
| S021 | 2016-11-18 | Special (immediate Track) |
| S020 | 2016-07-05 | Panel Track |
| S019 | ||
| S018 | 2016-06-02 | 30-day Notice |
| S017 | 2016-03-15 | 30-day Notice |
| S016 | 2015-07-24 | 135 Review Track For 30-day Notice |
| S015 | 2015-07-15 | Special (immediate Track) |
| S014 | 2015-06-18 | Normal 180 Day Track |
| S013 | 2015-03-17 | Normal 180 Day Track No User Fee |
| S012 | 2015-02-02 | 30-day Notice |
| S011 | 2014-11-12 | Normal 180 Day Track No User Fee |
| S010 | 2014-04-17 | Normal 180 Day Track No User Fee |
| S009 | 2013-09-20 | 30-day Notice |
| S008 | 2013-07-22 | Real-time Process |
| S007 | 2013-06-24 | 30-day Notice |
| S006 | 2013-06-19 | Special (immediate Track) |
| S005 | ||
| S004 | 2012-12-13 | Normal 180 Day Track No User Fee |
| S003 | 2012-12-13 | Normal 180 Day Track No User Fee |
| S002 | 2012-12-11 | Normal 180 Day Track |
| S001 | 2012-12-03 | Normal 180 Day Track |