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.
Addition of an in house supplier for sheath components and extension of the shelf life for a sheath component.
| Device | BARD LIFESTENT VASCULAR STENT SYSTEM |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2009-08-04 |
| Decision Date | 2009-09-01 |
| PMA | P070014 |
| Supplement | S003 |
| Product Code | NIP |
| 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. 1415 West 3rd St. tempe, AZ 85281 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P070014 | Original Filing | |
| S064 | 2023-01-06 | 30-day Notice |
| S063 | 2021-07-09 | 30-day Notice |
| S062 | 2021-05-04 | 30-day Notice |
| S061 | 2020-08-31 | 30-day Notice |
| S060 | ||
| S059 | ||
| S058 | 2018-08-20 | Special (immediate Track) |
| S057 | 2018-07-23 | 30-day Notice |
| S056 | 2018-06-05 | 30-day Notice |
| S055 | 2018-06-01 | Real-time Process |
| S054 | 2017-09-21 | 30-day Notice |
| S053 | 2017-08-29 | Normal 180 Day Track |
| S052 | 2016-09-30 | 30-day Notice |
| S051 | 2016-07-01 | Normal 180 Day Track No User Fee |
| S050 | ||
| S049 | 2015-11-10 | 30-day Notice |
| S048 | 2015-11-04 | Normal 180 Day Track |
| S047 | 2014-10-27 | Normal 180 Day Track |
| S046 | 2014-05-20 | 30-day Notice |
| S045 | 2014-05-12 | Normal 180 Day Track No User Fee |
| S044 | 2014-05-01 | Normal 180 Day Track |
| S043 | 2014-03-24 | 30-day Notice |
| S042 | 2014-02-25 | 30-day Notice |
| S041 | 2013-12-24 | Special (immediate Track) |
| S040 | 2013-08-28 | 30-day Notice |
| S039 | 2013-06-14 | 30-day Notice |
| S038 | 2013-03-29 | 30-day Notice |
| S037 | 2012-12-28 | Panel Track |
| S036 | 2012-11-09 | Normal 180 Day Track No User Fee |
| S035 | 2012-10-22 | 30-day Notice |
| S034 | 2012-08-22 | 30-day Notice |
| S033 | 2012-08-15 | Special (immediate Track) |
| S032 | 2012-04-06 | Real-time Process |
| S031 | 2012-04-02 | 30-day Notice |
| S030 | 2012-02-01 | 135 Review Track For 30-day Notice |
| S029 | 2011-10-28 | 30-day Notice |
| S028 | 2011-10-21 | 30-day Notice |
| S027 | 2011-10-03 | Real-time Process |
| S026 | 2011-09-26 | Special (immediate Track) |
| S025 | 2011-09-21 | Normal 180 Day Track No User Fee |
| S024 | 2011-09-08 | 30-day Notice |
| S023 | 2011-05-20 | Normal 180 Day Track No User Fee |
| S022 | 2011-03-10 | Normal 180 Day Track |
| S021 | ||
| S020 | 2010-12-13 | Normal 180 Day Track No User Fee |
| S019 | 2010-09-28 | 30-day Notice |
| S018 | 2010-09-09 | Normal 180 Day Track No User Fee |
| S017 | 2010-06-01 | 30-day Notice |
| S016 | 2010-05-28 | 30-day Notice |
| S015 | 2010-05-26 | 30-day Notice |
| S014 | 2010-04-13 | Normal 180 Day Track |
| S013 | 2010-03-22 | 135 Review Track For 30-day Notice |
| S012 | 2010-03-19 | 135 Review Track For 30-day Notice |
| S011 | 2010-03-16 | 30-day Notice |
| S010 | 2010-03-10 | Panel Track |
| S009 | 2010-01-29 | 135 Review Track For 30-day Notice |
| S008 | 2009-12-23 | 135 Review Track For 30-day Notice |
| S007 | 2009-12-14 | Normal 180 Day Track No User Fee |
| S006 | 2009-11-20 | Special (immediate Track) |
| S005 | 2009-10-30 | 30-day Notice |
| S004 | 2009-09-08 | 30-day Notice |
| S003 | 2009-08-04 | 30-day Notice |
| S002 | 2009-06-18 | 30-day Notice |
| S001 | 2009-06-02 | Real-time Process |