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 modifications to the instructions for use (ifu) to improve clarity by providing recommendations for appropriate guidewire selection and additional instructions for when resistance is encountered during catheter use.
| 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 | 2013-06-19 |
| Decision Date | 2013-07-19 |
| PMA | P100022 |
| Supplement | S006 |
| Product Code | NIU |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489 |
| 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 |