This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the supera® peripheral stent system. This device is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (sfa) and/or proximal popliteal artery, with reference vessel diameters of 4. 0 to 6. 5 mm, and lesion lengths up to 140 mm.
| Device | SUPERA PERIPHERAL STENT SYSTEM |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) |
| Date Received | 2012-11-16 |
| Decision Date | 2014-03-28 |
| Notice Date | 2014-04-21 |
| PMA | P120020 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 14M-0434 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120020 | Original Filing | |
| S030 | 2022-11-21 | 135 Review Track For 30-day Notice |
| S029 | 2022-09-30 | Real-time Process |
| S028 | 2022-09-30 | Real-time Process |
| S027 | 2021-09-08 | 30-day Notice |
| S026 | 2021-01-05 | Normal 180 Day Track |
| S025 | 2020-11-24 | 30-day Notice |
| S024 | 2020-09-01 | 30-day Notice |
| S023 | 2019-05-16 | 30-day Notice |
| S022 | 2019-02-08 | 30-day Notice |
| S021 | 2019-01-24 | 30-day Notice |
| S020 | 2018-09-05 | 30-day Notice |
| S019 | 2018-08-24 | 30-day Notice |
| S018 | 2017-12-20 | Normal 180 Day Track |
| S017 | 2017-09-28 | 135 Review Track For 30-day Notice |
| S016 | 2017-06-14 | 30-day Notice |
| S015 | 2016-09-08 | 30-day Notice |
| S014 | 2016-08-30 | 135 Review Track For 30-day Notice |
| S013 | 2016-05-09 | Normal 180 Day Track No User Fee |
| S012 | 2015-11-24 | 30-day Notice |
| S011 | 2015-08-10 | Normal 180 Day Track No User Fee |
| S010 | 2015-05-11 | 30-day Notice |
| S009 | 2015-04-28 | Real-time Process |
| S008 | 2015-04-13 | 30-day Notice |
| S007 | 2015-02-05 | 30-day Notice |
| S006 | 2014-08-29 | Normal 180 Day Track No User Fee |
| S005 | 2014-08-05 | 30-day Notice |
| S004 | 2014-05-27 | 135 Review Track For 30-day Notice |
| S003 | 2014-05-22 | Normal 180 Day Track |
| S002 | 2014-04-08 | Normal 180 Day Track No User Fee |
| S001 | 2014-03-31 | Normal 180 Day Track No User Fee |