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 astron peripheral self-expanding stent system. This device is indicated for improving luminal diameterin patients with iliac atherosclerotic lesions in vessel reference diameters between 4. 3mm and9. 5mm and lesion lengths up to 105mm.
| Device | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2014-12-18 |
| Decision Date | 2015-12-17 |
| Notice Date | 2015-12-22 |
| PMA | P140030 |
| Supplement | S |
| Product Code | NIO |
| Docket Number | 15M-4947 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140030 | Original Filing | |
| S015 | 2022-06-21 | 30-day Notice |
| S014 | 2021-09-15 | 30-day Notice |
| S013 | 2021-04-08 | 30-day Notice |
| S012 | 2021-03-25 | 30-day Notice |
| S011 | 2019-11-04 | 30-day Notice |
| S010 | 2019-07-15 | 30-day Notice |
| S009 | ||
| S008 | 2018-09-17 | 30-day Notice |
| S007 | 2018-04-16 | 30-day Notice |
| S006 | 2018-04-16 | 30-day Notice |
| S005 | 2017-10-11 | 30-day Notice |
| S004 | 2017-04-19 | 135 Review Track For 30-day Notice |
| S003 | 2017-02-22 | 30-day Notice |
| S002 | 2016-03-09 | 30-day Notice |
| S001 | 2016-02-11 | 30-day Notice |