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 a labeling change to add 0. 014” guidewires for use with the lifestent 5f vascular stent system.
| Device | Bard LifeStent 5F Vascular Stent System |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2018-06-01 |
| Decision Date | 2018-08-01 |
| PMA | P070014 |
| Supplement | S055 |
| Product Code | NIP |
| 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 | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |