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 lifestream balloon expandable vascular covered stent. This device is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries with reference vessel diameters between 4. 5 mm and 12. 0 mm, and lesion lengths up to 100 mm.
| Device | LIFESTREAM BALLOON EXPANDABLE VASCULAR COVERED STENT |
| Classification Name | Iliac Covered Stent, Arterial |
| Generic Name | Iliac Covered Stent, Arterial |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2016-07-21 |
| Decision Date | 2017-04-24 |
| Notice Date | 2017-04-25 |
| PMA | P160024 |
| Supplement | S |
| Product Code | PRL |
| Docket Number | 17M-2594 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BARD PERIPHERAL VASCULAR, INC. 1625 West 3rd St. tempe, AZ 85281-1740 |
| 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 |
|---|---|---|
| P160024 | Original Filing | |
| S012 | 2022-02-24 | Normal 180 Day Track No User Fee |
| S011 | 2021-09-30 | Real-time Process |
| S010 | 2020-09-28 | 30-day Notice |
| S009 | 2020-08-28 | 30-day Notice |
| S008 | 2020-04-21 | 30-day Notice |
| S007 | 2019-06-27 | Normal 180 Day Track No User Fee |
| S006 | 2018-11-28 | 30-day Notice |
| S005 | 2018-07-13 | 30-day Notice |
| S004 | 2018-03-23 | 30-day Notice |
| S003 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S002 | 2017-09-27 | Real-time Process |
| S001 | 2017-06-19 | 30-day Notice |