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 updates to the lifestream balloon expandable vascular covered stent labeling to incorporate the 3-year results of the bolster clinical study.
| 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 | 2019-06-27 |
| Decision Date | 2019-09-09 |
| PMA | P160024 |
| Supplement | S007 |
| Product Code | PRL |
| 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 | BARD PERIPHERAL VASCULAR, INC. 1625 West 3rd St. tempe, AZ 85281-1740 |
| 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 |