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.
Change to the cleaning process and solution during stent manufacturing.
| Device | ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2016-03-09 |
| Decision Date | 2016-04-13 |
| PMA | P140030 |
| Supplement | S002 |
| Product Code | NIO |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| 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 |