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.
Multiple changes to the measurement and laser cutting processes for the stent component.
| Device | Astron Pulsar/Pulsar-18 Stent System |
| Classification Name | Stent, Iliac |
| Generic Name | Stent, Iliac |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-04-16 |
| Decision Date | 2018-05-15 |
| PMA | P140030 |
| Supplement | S007 |
| Product Code | NIO |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |