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.
| Device | LifeStream® Balloon Expandable Vascular Covered Stent |
| Generic Name | Iliac Covered Stent, Arterial |
| Applicant | BARD PERIPHERAL VASCULAR, INC.1625 West 3rd St.tempe, AZ 85281-1740 PMA NumberP160024 Supplement NumberS012 Date Received02/24/2022 Decision Date08/23/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-24 |
| Decision Date | 2022-08-23 |
| PMA | P160024 |
| Supplement | S012 |
| Product Code | PRL |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 PMA NumberP160024 Supplement NumberS012 Date Received02/24/2022 Decision Date08/23/2022 Product Code PRL Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For A Manufacturing Site Located At Angiomed GmbH & Co. Medizintechnik KG, Wachhausstrasse 6, Karlsruhe Baden-Wurttemberg 76227, Germany For Supplying The Bare Metal Stent Component |
| 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 |