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 updated labeling to include clinical data from the bioflex-i study.
| Device | Astron Pulsar and Pulsar-18 Stent Systems |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2018-06-21 |
| Decision Date | 2018-08-22 |
| PMA | P160025 |
| Supplement | S005 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOTRONIK, INC. 6024 Jean Road lake Oswego, OR 97035 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160025 | Original Filing | |
| S015 | 2022-06-21 | 30-day Notice |
| S014 | 2022-04-20 | 30-day Notice |
| S013 | ||
| S012 | 2021-09-15 | 30-day Notice |
| S011 | 2021-04-08 | 30-day Notice |
| S010 | 2021-03-25 | 30-day Notice |
| S009 | 2019-11-04 | 30-day Notice |
| S008 | 2019-07-15 | 30-day Notice |
| S007 | ||
| S006 | 2018-07-10 | 30-day Notice |
| S005 | 2018-06-21 | Normal 180 Day Track No User Fee |
| S004 | 2018-04-16 | 30-day Notice |
| S003 | 2017-10-11 | 30-day Notice |
| S002 | 2017-06-14 | Normal 180 Day Track No User Fee |
| S001 | 2017-04-19 | 135 Review Track For 30-day Notice |