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.
Modifications to tooling fixtures.
| 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 | 2018-03-23 |
| Decision Date | 2018-04-19 |
| PMA | P160024 |
| Supplement | S004 |
| Product Code | PRL |
| 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 | 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 |