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.
Modifications to the ultrasonic pre-cleaning process and replacement of the ultrasonic cleaning machine.
| Device | Astron Peripheral Self-Expanding Nitinol Stent System |
| Generic Name | Stent, Iliac |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2021-09-15 |
| Decision Date | 2021-10-14 |
| PMA | P140030 |
| Supplement | S014 |
| 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 |