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 the bard® lifestent® vascular stent system. The bard® lifestent® vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (sfa) and popliteal artery with reference vessel diameters ranging from 4. 0 to 6. 5 mm.
| Device | BARD LIFESTENT VASCULAR STENT SYSTEM |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | BARD PERIPHERAL VASCULAR, INC. |
| Date Received | 2012-12-28 |
| Decision Date | 2016-05-31 |
| Notice Date | 2016-06-03 |
| PMA | P070014 |
| Supplement | S037 |
| Product Code | NIP |
| Docket Number | 16M-1455 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |