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 pulsar stent system and pulsar-18 stent system. These devices are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3. 0 to 6. 0mm and total lesion lengths up to 190mm.
| Device | ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BIOTRONIK, INC. |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-23 |
| Notice Date | 2017-03-29 |
| PMA | P160025 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 17M-1845 |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |